[{"country_short": "USA", "city": "Warwick", "description": "Principal Packaging Engineer\n\n\n\nIndustry Title\n/Category: Medical Device / Packaging Engineering\nJob ID: 2012-5645\n\nCareer Level: experienced\nLocation/Division: Warwick, RI / Davol\n\nRelocation: no\nPosted Date: 5/8/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nPrincipal Packaging Engineer\nDavol Inc.\nWarwick, RI\n\nPlan, organize and coordinate all Packaging Engineering and labeling related activities including project leadership and management to support development and commercialization of new products; line extensions; manufacturing maintenance of business activities; Cost Improvement Programs; testing and labeling activities to support ever-changing regulatory and industry requirements and investigation, evaluation, and implementation of new packaging concepts, materials and systems.\nSummary of Position with General Responsibilities:\n1.Provide cross-franchise support for new product development and line extension activities including:\n\u2022Concept development\n\u2022Project Plans/Schedules\n\u2022Design reviews and design for manufacturability\n\u2022Development of prototype packaging\n2.Plan and coordinate all packaging related activities to launch and commercialize new products and line extensions including:\n\u2022Concept and development of packaging methods and processes\n\u2022Coordination of all new tooling and equipment\n\u2022Coordination and support of all new vendor tooling and artwork\n\u2022Development and release of all new product and process documentation\n\u2022Generation of packaging specifications and associated documentation\n\u2022Development of packaging test plans\n\u2022Planning, ordering and coordination of all new component inventory\n\u2022Qualification and validation of all new equipment, processes and operations\n\u2022New product cost estimates for packaging\n\u2022Preparation of AFE(s)\n\u2022Evaluation and recommendation of new materials\n\u2022Performance of due diligence activities to support business development initiatives\n3.Plan and coordinate all packaging engineering activities to transfer new products and line extensions to manufacturing including:\n\u2022Development and management of packaging requirements to support the transfer plan\n\u2022Development and release of all packaging documentation\n\u2022Generation of all relevant test protocols and technical reports\n4.Provide packaging engineering support to manufacturing including the following:\n\u2022Assessment and development of action plans to overcome packaging related manufacturing and quality issues\n\u2022Support of cost improvement programs and manufacturing improvement plans related to product packaging\n5. Provide leadership for :\n\u2022Project teams requiring extensive packaging material/component/process activity\n\u2022Mentoring and developing junior level department personnel\n\nBasic Qualifications:\n\u2022B.S. degree in Packaging Engineering/Packaging Science or related discipline with a minimum of 8 years in packaging engineering & design or MS degree in Packaging Science or related discipline with a minimum of 6 years experience.\n\u2022Experience as a Project Manager and/or experience supervising direct reports.\n\u2022Ability to manage a variety of assignments at the same time.\n\u2022High level of written and verbal communications skills.\n\u2022Ability to conceptualize ideas, motivate and focus individuals and teams, and drive projects through to completion on time and on budget.\n\u2022Broad knowledge of properties for materials utilized in primary and secondary packaging, plus packaging methods and equipment.\n\u2022Strong knowledge of package test methods, process validation, bar coding, and international standards.\n\u2022Ability to travel occasionally.\n\nAdditional Desirable Qualifications Skills and Knowledge:\n\n* Experience in the medical device or pharmaceutical industries strongly preferred.\n* Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices.", "date_new": "2012-05-08 20:34:28", "url": "http://crbard.jobs/xml/28551674/job", "country": "United States", "company": "C. R. Bard", "title": "Principal Packaging Engineer", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 28551674}, {"country_short": "USA", "city": "Warwick", "description": "Sr. Manager, Regulatory Affairs\n\n\n\nIndustry Title\n/Category: Medical Device / Regulatory Affairs\nJob ID: 2012-5632\n\nCareer Level: management\nLocation/Division: Warwick, RI / Davol Inc.\n\nRelocation: yes\nPosted Date: 5/2/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nSr. Manager, Regulatory Affairs\nDavol Inc.\nWarwick, RI\nSummary of Position with General Responsibilities:\n\u2022Recruit, manage, develop and mentor regulatory professionals, manage budgets and tactics.\n\u2022Provide strategic global regulatory guidance to complex product lifecycle planning.\n\u2022Assist in regulatory due diligence and acquisition transfer activities.\n\u2022Through regulatory professional staff provide strategic input and technical guidance on regulatory requirements\nto product development teams for successful on-time submissions and clearances/approvals.\n\u2022Manage and execute pre-approval compliance activities.\n\u2022Assess the acceptability of quality, preclinical and clinical components for submission filing.\n\u2022Monitor impact of changing regulations on submission strategies and update internal stakeholders.\n\u2022Monitor and submit applicable reports and responses to regulatory authorities.\n\u2022Maintain annual licenses, registrations, listings and patent information.\n\u2022Ensure compliance with product post-marketing approval requirements.\n\u2022Review and approve labeling and promotion materials to comply with regulations and company policy.\n\u2022Provide regulatory support and appropriate follow-up to inspections and audits (eg. FDA, Notified Body).\n\u2022Develop, implement and manage appropriate regulatory procedures and systems.\n\u2022Submit/review change controls to determine the impact of change and consequent submission requirements.\n\u2022Provide regulatory input for product field action.\n\u2022Provide training for stakeholders on current and new regulatory requirements to ensure compliance.\n\u2022Conduct pre- IDE meetings with FDA and government agencies.\n\u2022Function as authorized delegate for function head when required.\n\u2022Represent Davol/Bard in professional associations, industry/trade groups (local/regional/international) and\nappropriate standards organizations.\n\nBasic Qualifications:\n\u2022B.S. Science, Engineering, or other medical or technical Degree or experience. Advanced regulatory affairs training required \u2013 MS, RAC, or other professional certification.\n\u2022Additional education highly preferred- MPH, MBA, MS, MA, PhD.\n\u2022Broad knowledge of materials and manufacturing processes, particularly concerning resorbable technologies, HTCP, biologics, pharmaceuticals.\n\u2022Knowledge of and experience (8-10 years) with regulatory submission for medical devices (IDE\u2019s, 510(k)\u2019s, PMA\u2019s, outside-US regions). Familiarity with combination products highly preferred.\n\u2022Must have demonstrated extensive working knowledge with the requirements for medical device registration/licensing in the EU, (Medical Device Directive), Japan, Canada, Australia, Latin America and Asia/Pacific.\n\u2022Working experience in medical products design and manufacturing quality system principles and practices.\n\u2022Ability to work independently with confidence, resolve conflicts, and negotiate with a win-win\u201d approach.\n\u2022Ability to work in a matrix/team environment with prior significant experience supervising and developing regulatory affairs professionals.\n\u2022Solid skill in written and oral communications. Positive energy and enthusiasm to work in a multi-task environment.\n\nEducation and/or Experience:", "date_new": "2012-05-02 18:59:43", "url": "http://crbard.jobs/xml/28333219/job", "country": "United States", "company": "C. R. Bard", "title": "Sr. Manager, Regulatory Affairs", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 28333219}, {"country_short": "USA", "city": "Warwick", "description": "Sr. Quality Systems Engineer\n\n\n\nIndustry Title\n/Category: Medical Device / Quality Systems\nJob ID: 2012-5626\n\nCareer Level: experienced\nLocation/Division: Warwick, RI / Davol Inc.\n\nRelocation: No\nPosted Date: 4/26/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nSr. Quality Systems Engineer\nDavol Inc.\nWarwick, RI\n\nThis position of Sr. Quality Systems Engineer reports to the Supplier Quality Engineering Manager and collaborates with Davol personnel to implement requirements of Davol\u2019s Quality Management System. This includes creation of appropriate systems and documentation associated with internal and external audits, training/education programs, quality system metrics and opportunities for quality system improvements. Scope includes all activities within the Davol Quality Management System.\nSummary of Position with General Responsibilities:\n\u2022Administer Internal Audit program to maintain compliance and ISO/EN certification and identify opportunities for improvement throughout the organization. Assist in representing Davol to ISO auditors regarding Quality System issues.\n\u2022Manage both Internal and External audits tracking progress in an audit software program; adequately document, track and efficiently close audits. Ensure proper DMAIC tools are used for corrective actions.\n\u2022Coordinate activities with Davol and its manufacturing sites in order to collect metrics related data on monthly/quarterly basis and provide monthly tracking metrics to the Quality Management Team.\n\u2022Assemble, analyze and report appropriate company metrics and the Total Quality System as part of Quarterly Management Reviews and monthly Quality and Operations RGL Reports. Routinely review the Total Quality System and Policies for adequacy and effectiveness with regards to business objectives and revise as necessary.\n\u2022Analyze processes identified as needing improvement and assist with identifying and implementing appropriate corrective or preventive actions. Assist in Failure Investigations to assure root cause is identified and verify effectiveness of corrective and preventive actions. Identify \"Best Practices\" from both internal and external sources and communicate them for incorporation throughout the organization. Perform \"Gap Analysis\" on current activities to identify goals for improvement.\n\u2022Manage internal auditor credentialing and documentation.\n\nBasic Qualifications:\n\u2022Bachelor of Science Degree in Engineering, Life Science or other technical discipline with emphasis in Quality Management and Statistics.\n\u2022Adequate training and experience (4-10 Yrs.) in developing, managing and auditing ISO 13485 quality systems. ASQ Certification CMQ/OE & CQA preferred.\n\u2022An understanding of statistical techniques and a preference for six sigma GB or BB; working knowledge and experience with DMAIC tools.\n\u2022Strong working knowledge of Regulatory Requirements (QSR, ISO, MDD).\n\u2022Ability to communicate and work effectively across departmental/facility lines.", "date_new": "2012-04-26 20:51:01", "url": "http://crbard.jobs/xml/28212372/job", "country": "United States", "company": "C. R. Bard", "title": "Sr. Quality Systems Engineer", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 28212372}, {"country_short": "USA", "city": "Warwick", "description": "Regulatory Affairs Specialist\n\n\n\nIndustry Title\n/Category: Medical Device/Regulatory/Clinical Affairs\nJob ID: 2012-5625\n\nCareer Level: experienced\nLocation/Division: Warwick, RI/Davol\n\nRelocation: No\nPosted Date: 4/26/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nRegulatory Affairs Specialist\nDavol Inc.\nWarwick, RI\n\nThe position of Regulatory Affairs Specialist will be responsible to provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical products regulations as well as provide regulatory support to marketed products.\nSummary of Position with General Responsibilities:\n\u2022Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)\u2019s, IDE\u2019s, PMA\u2019s).\n\u2022Assist in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales).\n\u2022Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.\n\u2022Prepare applications for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD).\n\u2022Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.\n\u2022Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.\n\u2022Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.\n\u2022Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.\n\u2022Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.\n\nBasic Qualifications:\n- B.S. degree or equivalent with emphasis on Life Sciences. Professional certifications preferred.\n- Knowledge and experience 1-5 years with regulatory requirements for medical devices including submission of IDE\u2019s, PMA\u2019s and 510(k)\u2019s, and CE mark technical files.\nAdditional Desirable Qualifications Skills and Knowledge:\n\n* Good oral and written communications skills and ability to work on cross-functional teams.\n* Working knowledge of statistics and electronic documentation and information systems.\n* Ability and desire to travel as needed.", "date_new": "2012-04-26 20:50:54", "url": "http://crbard.jobs/xml/28212368/job", "country": "United States", "company": "C. R. Bard", "title": "Regulatory Affairs Specialist", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 28212368}, {"country_short": "USA", "city": "Warwick", "description": "Supplier Quality Engineer\n\n\n\nIndustry Title\n/Category: Medical Device /Engineering\nJob ID: 2012-5618\n\nCareer Level: experienced\nLocation/Division: Warwick, RI / Davol\n\nRelocation: no\nPosted Date: 4/24/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nSupplier Quality Engineer\nDavol Inc.\nWarwick, RI\n\n\nThis position reports to the Supplier Quality Assurance Manager and is responsible for working with assigned suppliers to implement the requirements of the Davol supplier quality management program.\nSummary of Position with General Responsibilities:\n\u2022Auditing, monitoring, evaluating, reporting and improving supplier quality system performance and providing technical support to suppliers as determined by Davol management.\n\u2022As required, coordinating component and product quality testing for purposes of supplier and component qualification and improvement.\n\u2022As requested and approved, coordinating with other Bard Divisions to perform quality assessments on common suppliers to minimize costs to Bard/Davol and burden on the suppliers.\n\u2022Supporting Davol manufacturing sites as requested and approved in the assessments of their respective supplier quality systems for those suppliers designated within the scope of their supplier quality management responsibilities.\n\u2022Working closely with the Davol Purchasing Department in managing Davol\u2019s Supplier Base.\n\u2022Identifying and appropriately implementing statistical engineering tools and techniques to evaluate and implement supplier process capability and technical performance.\n\u2022Evaluating supplier quality systems and strategies compliant with regulatory requirements.\n\u2022Collecting and analyzing Quality data relating to Supplier Quality. Identifying and defining correction action required, initial corrective action with responsible function and follow-up to assure completion and effectiveness.\n\u2022Communicating potential for changing supplier quality risk to Davol management.\n\u2022Providing supplier quality engineering management to support new product design projects as required.\n\u202225-50% travel required as determined by business need.\n\nBasic Qualifications:\n\u2022 Bachelor\u2019s Degree required in Engineering or other technical discipline required.\n\u2022 Minimum of  2 to 5 years experience in a supplier quality/supplier auditing capacity or equivalent preferred or equivalent quality function.\n\u2022 Demonstrated ability to apply statistical quality engineering tools in a supplier environment.\n\u2022 Preferred working knowledge of medical device manufacturing systems and FDA regulations.\n\u2022 Effective communication and conflict resolution skills.\n\u2022 Effective problem solving techniques.\nAdditional Desirable Qualifications Skills and Knowledge:\n\n\u2022 ASQ-CQE, CQA preferred\n\u2022 Six Sigma Black Belt/Lean Manufacturing experience preferred.", "date_new": "2012-04-24 18:49:08", "url": "http://crbard.jobs/xml/28144069/job", "country": "United States", "company": "C. R. Bard", "title": "Supplier Quality Engineer", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 28144069}, {"country_short": "USA", "city": "Warwick", "description": "Associate Product Manager/Product Manager\n\n\n\nIndustry Title\n/Category: Medical Device / Marketing\nJob ID: 2012-5564\n\nCareer Level: experienced\nLocation/Division: Warwick, RI / Davol\n\nRelocation: no\nPosted Date: 4/4/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nAssociate Product Manager / Sr. Product Manager\nDavol Inc.\nWarwick, RI\n\n\nSupport the Franchise team objectives by leading and executing product management responsibilities with regard to product, programs, policies and processes.\nSummary of Position with General Responsibilities:\n\u2022Manage post-market surveillance (PMS) process for assigned product areas\n\u2022Train new and existing sales personnel on market segment, products and competition.\n\u2022Develop creative sales tools for project promotion.\n\u2022Understand the marketplace to develop educated forecasts and budget plans accordingly.\n\u2022Develop Sales Forecast for respective product line responsibility.\n\u2022Develop Expense Budget for respective product line responsibility.\n\u2022Development of sales tools to promote new business and defend existing business.\n\u2022Participate as marketing member on Product Development Teams.\n\u2022Make marketing contributions on diverse project teams.\n\u2022Implement new programs to help drive sales relevant to product line responsibilities.\n\u2022Manage product inventory with production planning.\n\u2022Build customer relationships with field sales force and surgeons.\n\u2022Speak to surgeons and clinicians on a one-on-one basis at conventions and meetings.\n\u2022Research and utilize direct-to-consumer promotion tactics.\n\u2022Respond to product inquiries from field sales force.\n\u2022Manage varying workload based on projects.\n\u2022Ability to refocus tasks depending on changes in the market.\n\u2022Develop and execute marketing strategies and tactics.\n\nBasic Qualifications:\n\u2022Bachelor's Degree.\n\u2022For Associate Product Manager: Minimum of one (1) to three (3) years marketing experience in Medical Device or combination Drug / Device with a Bachelor\u2019s Degree or zero (0) to two (2) years marketing experience (in medical, clinical or technical related field) with an MBA.\n\u2022For Product Manager: Minimum of three (3) years marketing experience in Medical Device or combination Drug/Device with a Bachelor\u2019s Degree or two (2) years marketing experience (in medical, clinical or technical related field) with an MBA.\n\u2022Prior experience in healthcare communications, education and promotions.\n\u2022Excellent written and oral communication skills.\n\u2022Demonstrates leadership capabilities.\n\u2022Solid analytical ability and business acumen.\n\u2022Ability to travel domestically and internationally.\n\nAdditional Desirable Qualifications Skills and Knowledge:\n\n* MBA preferred\n* Minimum of one year sales experience preferred", "date_new": "2012-04-11 12:37:17", "url": "http://crbard.jobs/xml/27814986/job", "country": "United States", "company": "C. R. Bard", "title": "Associate Product Manager/Product Manager", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 27814986}, {"country_short": "USA", "city": "Warwick", "description": "Principal Engineer\n\n\n\nIndustry Title\n/Category: Medical Device / Engineering\nJob ID: 2012-5581\n\nCareer Level: experienced\nLocation/Division: Warwick, RI / Davol Inc.\n\nRelocation: No\nPosted Date: 4/10/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nPrincipal Engineer\nDavol Inc.\nWarwick, RI\n\n\nLead product development activities of implantable medical devices from concept through product commercialization. Establish and foster relationships with clinicians and KOL\u2019s.\nSummary of Position with General Responsibilities:\n\u2022Technical Lead for development teams from idea generation through product launch\n\u2022Partner with Marketing to identify unmet customer needs and translate them into product specifications\n\u2022Develop new product concepts that meet global customer needs\n\u2022Coordinate design and development activities to ensure project milestones are achieved\n\u2022Develop testing protocols, DOE\u2019s and summary reports in support of new product development activities.\n\u2022Lead FMEA and design verification/validation activities\n\u2022Coordinate prototype fabrication and testing\n\u2022Develop project timelines and budgets and track progress\n\u2022Develop intellectual property (IP)\n\u2022Work closely with cross functional team members to ensure project commitments are achieved\n\u2022Work closely with manufacturing to meet project milestones\n\u2022Manage external development partners\n\u2022Present project updates to Sr. Management Team\n\nBasic Qualifications:\n\u2022BS in Engineering,\n\u2022Minimum of 8 years experience in product development in the surgical, disposable products or related industries with a Bachelor\u2019s Degree or minimum of 6 years experience in product development in the surgical, disposable products or related industries with a Master\u2019s Degree.\n\u2022Experience interfacing and building relationships with Clinicians and KOL\u2019s\n\u2022Familiar with Concept Engineering (i.e., VOC, observational research, ODI, etc..)\n\u2022Proven track records of developing products from concept to launch\n\u2022Knowledge of cGMP\u2019s and FDA/CE Mark regulatory requirements\n\u2022Experience with Design for Six Sigma (DFSS) tools and methodology\n\u2022Excellent verbal and written communication skills\n\u2022Track record of managing projects and budgets\n\u2022Ability to work independently (self directed)\n\u2022Ability to travel occasionally\n\nAdditional Desirable Qualifications Skills and Knowledge:\n\n* Master\u2019s Degree preferred.", "date_new": "2012-04-11 12:37:01", "url": "http://crbard.jobs/xml/27814967/job", "country": "United States", "company": "C. R. Bard", "title": "Principal Engineer", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 27814967}, {"country_short": "USA", "city": "Warwick", "description": "Advanced Quality Engineer/Sr. Advanced Quality Engineer\n\n\n\nIndustry Title\n/Category: Medical Device\nJob ID: 2012-5580\n\nCareer Level: experienced\nLocation/Division: Davol / Warwick, RI\n\nRelocation: Yes\nPosted Date: 4/10/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nAdvanced Quality Engineer / Sr. Advanced Quality Engineer\nDavol Inc.\nWarwick, RI\n\nThe position of the Advanced Quality Engineer/Sr. Advanced Quality Engineer is responsible to assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy.  This individual will represent quality interests and concerns on project teams and report to the Manager of Advanced Quality Engineering.\n\n\nSummary of Position with General Responsibilities:\n*Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors as required based on level.\n*Lead or Support Quality Engineering Projects to improve Quality Systems and Procedures.\n*Development of Test Protocols and Final Reports to support Regulatory 510K or PMA submissions.\n*Development of Risk Management Documents, including the DFMEA, while coordinating input from the other Design Sub-team members.\n*Development of the Design Verification Protocol and Design Verification Report.\n*Provide input into the product Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents as defined per Davol\u2019s product development process.\n*Support front end product innovation process activities to support new technology integration and transfer to new product development teams.\n*Determine the degree of Biocompatibility testing required as per ISO10993 requirements.\n*Develop test protocols and release a final report on Shelf Life Studies in support of expiration dating.\nLead Supplier part qualification activities.\n*Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of test methods used to assess the safety and efficacy of devices.\n\n\n\nBasic Qualifications:\n\u2022Bachelor or Masters Degree in Engineering or Technical Sciences or equivalent combination of Bachelors Degree and related work experience.\n\u2022AQE (2-5) year\u2019s minimum experience, Senior AQE (5-8) year\u2019s minimum experience in Quality Engineering discipline including design controls, product/process validation, supplier management, and technical problem solving.\n\u2022An appropriate level of competence in Quality Technology including statistical techniques and six sigma tools including sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.\n\u2022Applied knowledge of the requirements of FDA QSR\u2019s and ISO Quality Systems.\n\nAdditional Desirable Qualifications Skills and Knowledge:\n\n* CQE certificate from American Society for Quality a plus.\n* Ability to work with and motivate people.\n* Good oral and written communication skills.", "date_new": "2012-04-11 12:36:50", "url": "http://crbard.jobs/xml/27814960/job", "country": "United States", "company": "C. R. Bard", "title": "Advanced Quality Engineer/Sr. Advanced Quality Engineer", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 27814960}, {"country_short": "USA", "city": "Warwick", "description": "Advanced Quality Engineer\n\n\n\nIndustry Title\n/Category: Medical Device\nJob ID: 2012-5544\n\nCareer Level: experienced\nLocation/Division: Davol Inc / Warwick, RI\n\nRelocation: no\nPosted Date: 4/10/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nAdvanced Quality Engineer\nDavol Inc.\nWarwick, RI\n\n\n\nThe position of Advanced Quality Engineer is responsible to represent quality on design teams and assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to product quality, safety and efficacy.  This individual will be an active team member and collaborator on new product development and product enhancement project teams for implantable medical devices.\nSummary of Position with General Responsibilities:\n\u2022Support design and development activities for new product development including regulatory submissions.\n\u2022Lead product and process risk assessment activities such as Hazards analysis, and Design Failure Modes & effects Analysis (DFMEA).\n\u2022Support design validation and process validation activities.\n\u2022Lead shelf life/stability testing activities for new products.\n\u2022Develop, document and validate inspection and test methods to support design verification/validation, in-process inspection, and final inspection activities.\n\u2022Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities.\n\u2022Evaluate product complaints and initiate corrective actions as needed to improve product quality and work with manufacturing facilities in resolving quality issues.\n\u2022Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.\n\n\nBasic Qualifications:\n\u2022Bachelor Degree in Technical discipline required.\n\u20223 years minimum experience in Quality Engineering discipline including design controls, product/process validation, and technical problem solving.\n\u2022Strong design control experience in a medical device environment.\n\u2022A high level of competence in Quality Technology including statistical techniques and six sigma tools.\n\u2022Applied knowledge of the requirements of FDA QSR\u2019s and ISO Quality Systems.\n\nAdditional Desirable Qualifications Skills and Knowledge:\n\n* Demonstrated collaboration and leadership skills on New Product Development Teams.\n* CQE and/or Six Sigma certification a plus.", "date_new": "2012-04-11 12:36:02", "url": "http://crbard.jobs/xml/27814905/job", "country": "United States", "company": "C. R. Bard", "title": "Advanced Quality Engineer", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 27814905}, {"country_short": "USA", "city": "Warwick", "description": "Sr. Regulatory Affairs Specialist\n\n\n\nIndustry Title\n/Category: Medical Device/Regulatory Affairs\nJob ID: 2012-5391\n\nCareer Level: experienced\nLocation/Division: Warwick, RI/Davol\n\nRelocation: No\nPosted Date: 1/6/2012\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nSr. Regulatory Affairs Specialist\nDavol Inc.\nWarwick, RI\n\nThe position of Regulatory Affairs Specialist will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical products regulations. Provide regulatory support to marketed products.\nSummary of Position with General Responsibilities:\n\u2022Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)\u2019s, IDE\u2019s, PMA\u2019s).\n\u2022Assist in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales).\n\u2022Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.\n\u2022Prepare applications for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD).\n\u2022Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.\n\u2022Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.\n\u2022Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.\n\u2022Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.\n\u2022Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.\n\nBasic Qualifications:\n- B.S. degree or equivalent with emphasis on Life Sciences. Professional certifications preferred.\n- Knowledge and experience 4-6 years with regulatory requirements for medical devices including submission of IDE\u2019s, PMA\u2019s and 510(k)\u2019s, and CE mark technical files.\nAdditional Desirable Qualifications Skills and Knowledge:\n\n* Professional certifications preferred.\n* Good oral and written communications skills and ability to work on cross-functional teams.\n* Working knowledge of statistics and electronic documentation and information systems.\n* Ability and desire to travel as needed.", "date_new": "2012-01-06 21:46:25", "url": "http://crbard.jobs/xml/25749627/job", "country": "United States", "company": "C. R. Bard", "title": "Sr. Regulatory Affairs Specialist", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 25749627}, {"country_short": "USA", "city": "Warwick", "description": "Senior Advanced Quality Engineer\n\n\n\nIndustry Title\n/Category: Medical Device\nJob ID: 2011-5116\n\nCareer Level: experienced\nLocation/Division: Davol / Warwick, RI\n\nRelocation: Yes\nPosted Date: 6/29/2011\n\nClose Date: .. \nC. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.\n\nWe expect the highest levels of quality, integrity, service, and innovation from our employees \u2013 on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.\n\nBe Your Best at Bard \u2013 and ultimately, you can have an impact on the lives of people around the world.\n\nApply for this position\n* Refer a friend to this job\nMore information about this job:\nOverview:\nSr. Advanced Quality Engineer\nDavol Inc.\nWarwick, RI\n\nThe position of the Senior Advanced Quality Engineer is responsible to assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy.  This individual will represent quality interests and concerns on project teams and report to the Manager of Advanced Quality Engineering.\n\nSummary of Position with General Responsibilities:\n*Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors as required based on level.\n*Lead or Support Quality Engineering Projects to improve Quality Systems and Procedures.\n*Development of Test Protocols and Final Reports to support Regulatory 510K or PMA submissions.\n*Development of Risk Management Documents, including the DFMEA, while coordinating input from the other Design Sub-team members.\n*Development of the Design Verification Protocol and Design Verification Report.\n*Provide input into the product Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents as defined per Davol\u2019s product development process.\n*Support front end product innovation process activities to support new technology integration and transfer to new product development teams.\n*Determine the degree of Biocompatibility testing required as per ISO10993 requirements.\n*Develop test protocols and release a final report on Shelf Life Studies in support of expiration dating.\nLead Supplier part qualification activities.\n*Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of test methods used to assess the safety and efficacy of devices.\n\n\n\nBasic Qualifications:\n\u2022Bachelor Degree in Engineering or Technical Sciences or equivalent combination of Bachelors Degree and related work experience.\n\u2022Senior AQE (5-7) year\u2019s minimum experience in Quality Engineering discipline including design controls, product/process validation, supplier management, and technical problem solving.\n\u2022An appropriate level of competence in Quality Technology including statistical techniques and six sigma tools including sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.\n\u2022Applied knowledge of the requirements of FDA QSR\u2019s and ISO Quality Systems.\n\nAdditional Desirable Qualifications Skills and Knowledge:\n\n* CQE certificate from American Society for Quality a plus.\n* Ability to work with and motivate people.\n* Good oral and written communication skills.", "date_new": "2011-06-29 22:11:26", "url": "http://crbard.jobs/xml/22090735/job", "country": "United States", "company": "C. R. Bard", "title": "Senior Advanced Quality Engineer", "reqid": null, "state": "Rhode Island", "state_short": "RI", "location": "Warwick, RI", "uid": 22090735}]