Principal Research And Development Engineer

Start Recruiting is excited to partner with a Twin Cities based, clinical stage, start-up in the search for a Principal R&D Engineer who is experienced the the development of Class III Structural Heart implantable devices.Position Summary: The Principal Engineer will be responsible for design and development of investigational structural heart valve. This position will lead next generation projects and ensure a rapid introduction to clinic of new designs. The primary focus of this position will be valve design, development and testing.Key Responsibilities:Serve as the R&D technical lead for the development of our next generation valves, and provide technical leadership related to product design.Design and develop product(s) in compliance with the company's Design Control requirements and applicable regulatory requirements.Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.Supporting regulatory submissions for next generation devices, by ensuring compliance to requirements (US & OUS).Working cooperatively with process development, quality, manufacturing, regulatory and clinical to ensure project success.Experience & Skill RequirementsBS in Mechanical Engineering, Biomedical Engineering, or related field.10+ years of engineering experience with a Bachelor's degree OR 7+ years with Master's Degree (preferred experience with structural heart devices)Heart valve design experience (preferred transcatheter heart valve design experience)Heart valve testing experience (e.g. hydrodynamic testing, AWT, simulated use testing)Technical report writing for FDA & OUS submissionsPrior experience with design controls and PDPTechnical proficiency with engineering software (e.g. Solidworks, Minitab, Design Expert)Must work Onsite in Maple Grove, MNThis is an opportunity to be part of an innovative and driven team who is solving critical problems in the structural heart space!This is an ONSITE position with no ability to be remote or hybrid.VISA Sponsorship support will not be offeredStart Recruiting, Inc. is a boutique recruitment firm located in Minneapolis, MN with expertise in representing technical and technical leadership opportunities within the medical device community.We partner with F500, mid-sized, emerging and start-up companies.Over 20 years of experience developing relationships with our clients and candidatesRepresent opportunities within the "hidden" job marketFunctions we serve include R&D, Process Development, Manufacturing, Systems Engineering, Software Development, Quality, Regulatory, and Project / Program Management.Whether you are early in your career, or seeking a senior level leadership role, we would like the opportunity to learn more about your career goals and how we can help you achieve them through your employment transition.

Created: 2025-02-14