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:Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field5+ years of MEDICAL DEVICE experience (4+ with an advanced degree).Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.Ability to apply DFX principles to create designs that can scale.Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T.Track record of taking design concepts from prototyping stage through to design maturation.Proven design capabilities in two or more of the following key areas: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.Experience creating and running simulations (CFD, FEA) to inform product development.Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data.Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.Strong problem-solving and analytical skills, with a hands-on approach to product development and testing.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.

Created: 2025-10-02