Sr R&D Engineer

Overview:Our client is a distinguished medical device manufacturer who specializes in the development and commercialization of innovative medical devices to improve patient lives around the world. Our client needs a Senior R&D Engineer to lead integration-focused design and development efforts, ensuring successful incorporation of new technologies into existing systems. This role requires strong technical expertise, deep knowledge of design controls, and the ability to operate independently while influencing cross-functional teams.This is a role will run through the end of 2026 with strong likelihood for extension. This is an onsite role in the greater Minneapolis area 4 days/week. ResponsibilitiesLead integration workstreams, including interface definition, requirements alignment, planning, and technical decision-making.Own design control deliverables (user needs, inputs/outputs, traceability, risk management, V&V, DHF) to ensure regulatory and procedural compliance.Conduct feasibility studies, prototype development, and testing to optimize designs and support integration across device iterations.Perform root cause analysis, resolve technical issues, and proactively identify and mitigate integration risks.Partner with quality, manufacturing, supplier engineering, and regulatory teams to drive execution and communicate technical information effectively.QualificationsBS in Mechanical, Biomedical, Materials Science, or related field (advanced degree preferred)6+ years industry experience, or 4+ years with advanced degreeExperience in catheter and/or single-use medical device developmentStrong knowledge of design controls, risk management, and documentation (V&V, DHF, traceability, change control)Proven ability to lead workstreams and influence cross-functional teamsStrong problem-solving and communication skills; able to work independentlyAbility to travel up to 15%Preferred QualificationsExperience with technology or product integration (e.g., acquisitions, platform integration)Background in balloon catheter or catheter-based systemsExperience with test method developmentKnowledge of Class II/III medical device regulationsFamiliarity with industry quality systemsSelf-starter with strong accountability, adaptability, and comfort working in ambiguity