Senior Research And Development Engineer

Summary :

Commercial-Stage, 200-Person Minimally-Invasive Interventional Technology medical device company. Very well-funded with $50MM financing recently secured.

Job Details :

We are looking for a Senior R&D Sustaining Engineer to drive design solutions and support process enhancements for commercialized products, working closely alongside the systems, vision and sensors, and software R&D teams, to catalyze the advancement of an innovative, single-use minimally-invasive treatment devices. You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to integrate and implement these solutions into our commercialized product(s).

Primary Responsibilities :

• Lead and inform the design, development and qualification strategy for design-related product enhancements and line extensions in response to internal and / or external feedback.
• Lead design-related root cause analysis efforts, and drive corrective and preventive actions.
• Serve as an R&D SME for projects lead by cross-functions, and partner with cross-functional teams to gain alignment on qualification strategies.
• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.
• Collaborate with the Post-Market Surveillance team to support effective root cause analysis of device issues returning from the field.
• Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.
• Use SolidWorks to create well-defined models, assemblies, and engineering drawings.
• Support the generation of new or revised product requirements and engineering specifications.
• Create and execute protocols, and author associated reports and risk documentation, developing and validating new test methods as needed.
• Effectively communicate project progress, results, and risks to relevant stakeholders.
• Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing as needed, ensuring alignment with project goals and timelines.

Requirements :

Must Have US Work Authorization or be a US Citizen (No Sponsorships or C2C candidates)

Local Candidates preferred, however some assistance may be offered for well-qualified candidates from out of the area.