Sr. Research & Development Engineer, Device

The Senior Research & Development (R&D) Engineer plays a pivotal role in designing, developing, and testing new and innovative medical devices, ensuring adherence to the company’s Quality System. This multifaceted role involves collaboration with cross‑functional teams to drive product development from concept to validation, all while maintaining rigorous quality, regulatory, and manufacturing standards.

The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

• Design and develop medical devices made from metal and/or polymer. Work with vendors to develop effective and robust products and packaging solutions.
• Lead the product development process from concept through Process Validation, ensuring alignment with performance specifications, quality standards, and regulatory and manufacturing requirements.
• Assemble devices and sub‑assemblies for R&D using standard manufacturing practices such as adhesive bonding, heat bonding/fusing, cutting/trimming, cleaning, packaging, and tools such as UV cure equipment.
• Be able to work in a Controlled Environment Room (CER) following standard industry practices. Interface with assemblers to train and guide in assembly of devices for verification/validation.
• Design and fabricate testing models and/or fixtures as needed.
• Perform functional tests of devices and sub‑assemblies, work with QA to develop standard test methods.
• Perform functional testing, such as (but not limited to) strength of bond joints and flow analysis using equipment such as Instron tensile testers, pressure transducers and data acquisition software (i.e Labview).
• Author technical documents such as test protocols/reports, lab notebook studies, and documents supporting regulatory submissions (i.e. IND, PMA, CE Mark).
• Work with vendors to assist in developing manufacturing work instructions, as necessary.
• Utilize statistical methods as required for the planning of required sample sizes necessary in testing. Analyze test results, culminating in comprehensive test reports. Draw conclusions/recommendations from the results.
• Utilize Solid Works to develop detailed 3‑D CAD models and drawings of medical devices, and/or packaging. Includes components, subassembly, and top‑level drawings.
• Support pre‑clinical studies such as animal studies or training studies.
• Inspect incoming parts and components, in‑process assemblies using standard tools such as calipers, pin gauges, snap gauges, smart scope systems, microscopes.
• Collaborate with internal and/or external resources (suppliers) to produce prototype device components.
• Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.
• Manufacture devices following simple to complex manufacturing process instructions and work instructions and maintaining Good Documentation Practices (GDP).
• Abide by company quality system requirements, such as training to and following quality and procedure documents.
• Contribute to the company’s overall Risk Management efforts including potential contribution to formal ISO 14971 Risk Management requirements, varied design, process, and use FMEAs, including but not limited to consideration of risk in Change Control, validations and verifications, CAPA, complaints, non‑conforming materials, Design Controls, as well other Quality System elements (Process Control, Tooling and Equipment, Calibration, Supplier Controls, etc.) as needed.

BS in Engineering with 5+ years of medical device design and testing experience as well as:

• Experience working in a clean room environment
• Experience performing R&D work within a Design Control environment
• Experience with combination products a plus
• Experience with energy delivery systems (e.g., cryoablation) a plus
• Basic computer skills in MS Office, Solid Works and solid modeling
• Ability to work in a fast‑paced environment
• Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed
• Demonstrated ability to successfully work within a cross‑functional team
• Ability to organize work and prioritize tasks
• Excellent…