R&D Engineer III; Sustaining

Job Summary

This position will lead sustaining engineering projects, driving process improvements, design changes, and various project management tasks of medical products and capital devices. This position will learn and utilize relevant engineering tools to deliver high quality, cost‑effective solutions. Candidates will be able to independently and collaboratively work with stakeholders to handle sustenance engineering projects including but not limited to product design changes, labelling and packaging changes, stewardship requests and obsolescence projects.

Own the end-to-end execution of sustenance projects, including obsolescence, product stewardship requests and sustaining change requests. Extract, collect, analyze, and summarize data files and report to stakeholders.

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.

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

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

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.

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.

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.

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.

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

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.
• 4 to 7 years of industrial experience 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.
• 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, interpret results, and write reports.
• 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…