New Product Quality Engineer

Job Description Summary The Senior Quality Engineer is responsible for supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering. The incumbent works multi-functionally with teams on new product design, design transfer, risk management, process/product design, quality improvement projects (QIPs) and cost... to win (CTW) projects. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. General Functions, Specific Responsibilities, and Authority: The Senior Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.), as well as R&D, Manufacturing, Sales, Marketing, Operations, and Finance. The Senior Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to new product development regulatory submissions and regional expansions, with DCHU on complaint handling/resolution and field actions pre-/post - product launch, Packaging COE on new product packaging projects and changes, Sterility Assurance on sterilization process (re)validations and with Platform Management regarding product design and development, as well as design transfer activities. Product Development: • Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors. • Support Pre-Concept Front End Product Innovation Process activities for new technologies. • Lead Quality Engineering Projects to improve Quality systems and Procedures. • Develop and maintain product Design History File (DHF) & Drug Master File (DMF). • Development of the Risk Management File in accordance with ISO14971, coordinating input from the other Design Sub-team members including the development of the design, process, and usability FMEAs. • Development of Design Verification Protocols and subsequent Design Verification Reports including analysis of all data and decisions on design acceptability. • Development of Design Validation Protocols and subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability. • Provide input into the project Design Inputs, Design Outputs, Product Specifications, Product Development Plan, and applicable design control documents as defined per BD’s product development process and 21CFR 820. • Development of Test Protocols and Final Report to support Regulatory 510K, PMA, (A)NDA, CE mark and International registrations. • Determine the degree of Biocompatibility testing required for product changes and new product development efforts as per ISO10993 and company procedures working with BD COEs. • Develop or assist in development of inspection and test methods per product specifications. • Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating. • Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices. • Develop shelf life and stability test protocols and reports as required. Process Development: • Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product. • Support the development of manufacturing control plans for internal and outsourced processes. • Support (or lead) development of the PFMEA. • Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment. • Design and qualify inspection test methods and equipment. • Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, CMC, and ISO13485 requirements. • Lead supplier part qualification activities including mold qualification and DOEs. • Support Process Transfers to the Production facilities. Other: • Support the disposition investigation and decisions of rejected nonconforming components and products; conduct MRB action when required. • Organize and generate detailed quality information reports to show trends and the impact of process improvements. • Support Design / Process Transfers to the production facilities. • Conduct other Quality Control Projects as assigned by the Manager of Quality Engineering. • Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances. • Perform DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required. • Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted. • Support goals of the Quality Assurance / Engineering Department. • Mentor junior QE staff Knowledge, Education, and Skills Required: • Bachelor's degree in Engineering or Chemistry • 5 - 8 years Design Control and Risk Management experience with pharmaceutical, combination products, or medical devices. • Pharmaceutical or combination product experience, preferred. • ASQ Certified Quality Engineer (CQE) or advanced degree preferred. • Experience operating in GLP, GMP, and GDP. • Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred. • Attentiveness to details with strong organizational skills. • Ability to work proactively and independently. • Ability to multi-task and efficient in time management. • Excellent verbal communication and interpersonal skills. • Ability to work in a team environment. • Proficiency in Excel, Word, and other desktop/general business systems. • Approximately 15 - 20% travel may be required. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit https://bd.com/careers Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. SWE PDN Primary Work Location USA RI - Warwick Additional Locations USA IL - Vernon Hills Work Shift