Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
To assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and crossfunction collaborator on new product development and product enhancement project teams for implantable medical devices. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs. The scope of the work is across all phases of development activity, including vendors and suppliers. The work has an impact on product function, product release dates, product quality, and product costs.
Essential job Functions
· Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
· Development of Test Protocols and Final Report to support Regulatory 510K, PMA, CE mark and International registrations.
· Support Pre-Concept Front End Product Innovation Process activities for new technologies.
· Lead Quality Engineering Projects to improve Quality systems and Procedures.
· Development of the DFMEA, coordinating input from the other Design Sub-team members.
· Development of the Final Design Verification Protocol and the subsequent Final Design Verification Report including an analysis of all data and a decision on design acceptability.
· Development of the Design Validation Protocol and the subsequent Design Validation Report including an analysis of all data and a decision on design acceptability.
· Provide input into the project Design Input Summary (DIS), Product Performance Specification (PPS), Product Development Plan (PDP), and applicable design control documents as defined per Davol’s product development process.
· Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures. Co-ordinate the testing at an outside lab and document results.
· 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 device s.
· Develop shelf life and stability test protocols and reports as required.
· 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, and ISO13485:2003 requirements.
· Lead supplier part qualification activities including mold qualification and DOEs.
· Support Process Transfers to the Production facilities.
· Make dispositions 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 Process Transfers to the production facilities.
· Conduct other Quality Control Projects as assigned by the Manager of Advanced 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 Department.
· B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, Technical science, or equivalent combination of Bachelors Degree and related work experience.
· With B.S., minimum of 5 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving
· With M.S., minimum 4 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving
· A high level of competence in Quality Technology, 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.
· Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs).
· Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001.
· Travel flexible
· Good oral and written communication skills.
· Ability to work with and motivate people.
- Quality & Regulatory Affairs Personnel
- Production Supervisors & Managers
- Manufacturing & Ind. Engineers
- Product Managers
- Product Development Engineers
- Other Bard Divisions
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.
BD and Covid-19: To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location, but is temporarily remote-based due to Covid-19. Any offer of employment is contingent upon the candidate reporting to work at the site if/when associates are requested to return to the workplace.
Primary Work LocationUSA RI - Warwick
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- Team player
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.