R&D Engineer III

Advancing the World of Health

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Sustaining:

• Own the end-to-end execution of product engineering projects, including Sustaining Change Requests, Product Stewardship requests, and Obsolescence projects. Extract, collect, analyze, and summarize data files and report to stakeholders.

Design:

• Designs, develops and implements products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards. Plans, coordinates and builds test parts for engineering evaluation, pre-clinical studies and clinical studies. Makes and presents engineering decisions.
  
  Participates and leads cross-functional teams through design and development stages.

Process Development:

• Develop new or existing processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate. Develops process equipment and tooling, including specification development, vendor selection and negotiation.

Documentation:

• Prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications and drawings. Prepares verification and validation protocols and reports.

Test Method Development:

• Develop or modify test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.

Testing:

• Perform lab bench testing, conduct engineering and competitor evaluations, development unit testing. Plan, develop, coordinate and execute verification and validation activities for existing products and processes.

Training:

• Train technicians in design and process development as well as new/modified test methods. Conduct process development training with operations and quality assurance in conjunction with R&D technicians.

Supervisory/mentoring/coaching:

• Mentor/coach R&D technicians through activities like process development, R&D materials/inventory control etc. May supervise or manage technicians, engineering interns or associate engineers.

Fiscal:

• Participation in our creation and control of a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.

Other Responsibilities may include, however are not limited to:

• 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.

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
• Minimum of 6 years of industrial experience, preferably in R&D or process development.
• 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.
• Training in Six Sigma or Design for Six Sigma.

• Master's degree in relevant engineering discipline plus 1-3 years medical device or equivalent industry experience
• Experience in R&D or process development in medical device or other regulated FDA/QSR and ISO environment
• Knowledge of cGMP and GLP.
• Experience creating and executing project plans.
• Experience and willingness to lead cross functional teams, across multiple time zones (Domestic and International).
• Experience in project management tools and methodologies
• Basic tooling, design and drafting knowledge.
• Proficient in statistical software with ability to analyze data,…