About the role:

The R&D Engineer plays a critical role in the design, development, and implementation of new products, processes, test methods, and equipment for medical devices. This position is responsible for converting conceptual ideas into practical engineering solutions, supporting continuous improvement through process studies, and ensuring compliance with clinical and international standards. The engineer works closely with cross-functional teams to develop tangible engineering specifications and drawings, select appropriate materials and vendors, and guide product development from concept through validation.

In this role, the R&D Engineer leads the planning and execution of testing protocols for both engineering and clinical studies, develops and validates new processes and test methods using statistical tools like DOE, and prepares essential documentation such as SOPs, technical reports, and specifications. They train technicians, support quality and regulatory functions, manage project budgets, and drive design and process improvements through rigorous evaluation and root cause analysis. Collaboration with manufacturing, quality assurance, and regulatory teams ensures all systems meet internal and external guidelines.

Main responsibilities will include:

• Designs, develops and implements new 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.
• Develops new processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate, including new process equipment and tooling, 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, and prepare verification and validation protocols and reports.
• 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..
• Perform lab bench testing, conduct engineering and competitor evaluations, and conduct development unit testing, develop, coordinate, and complete verification and validation activities for new products and processes.
• Train technicians on new design and process development, and new test methods, and conduct new process development training with operations and quality assurance in conjunction with R&D technicians.
• Participation in creating and controlling a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.
• Support Manufacturing, Quality, Regulatory & R&D to ensure systems follow all internal and external guidelines.
• Support/lead design, 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 field, or equivalent experience.
• 4 years of industrial experience in R&D or process development in regulated environments.
• Evidenced hands-on technical curiosity.
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to complete validation.
• Ability to build and implement project plans.
• Basic tooling, design and drafting knowledge.
• Excellent oral and written communication skills.
• Ability to analyze data, interpret results, and write reports. Proficient in statistical software.