Job Description
Senior R & D Engineer leads research and development efforts of complex medical devices, supporting sustaining activities for existing products and driving project planning, innovative design, and testing.
The Senior R & D Engineer works cross-functionally to lead research and development efforts of complex medical devices. The position supports sustaining activities for existing products, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting.
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.
Main Responsibilities:
- Designs, develops and implements changes to existing products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings and makes and presents engineering decisions.
- Participates and leads cross-functional teams in the design changes of a medical device and contribute ideas and/or generate intellectual property submissions.
- Supports sustaining activities for existing medical devices.
- Develops or changes processes by understanding key process inputs and outputs, using statistic methods such as DOE as appropriate.
- Develops or changes process equipment and tooling, including specification development, vendor selection and negotiation.
- Write and review change control plans, design reviews, technical documents and reports.
- Prepare and approves verification and validation protocols and reports and develop and implements procedures/policy.
- Develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.
- Conduct engineering and competitor evaluations, and development unit testing.
- Plan, develop, execute and manage verification and validation activities for changes to products and processes.
- Train technicians and engineers on new design and process development as well as new test methods.
- Mentor/coach R&D technicians and engineers through New Product Development and/or Change Control Process activities.
- Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
- Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.
About the Role:
- B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
- 6-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
- Demonstrated hands-on technical aptitude.
- Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
- Ability to create and execute project plans.
- Ability to lead cross functional teams.
- Basic tooling, design and drafting knowledge.
- Excellent oral and written communication skills.
- Ability to analyze data, interpret results, and write reports. Proficient in statistic software.