Principal R&D Engineer

Principal R&D Engineer (Structural Heart / Catheter Systems)Location: Minneapolis, MNOverviewWe are seeking a Principal R&D Engineer to serve as a technical leader in the design and development of advanced catheter-based systems within the structural heart space.This is a high-impact, pre-commercial role where you will help shape a next-generation therapy from concept through clinical readiness and into commercialization. You’ll work at the intersection of engineering, clinical insight, and regulatory strategy—contributing directly to a program that is moving through critical development milestones.If you’re motivated by solving complex engineering challenges and want to play a visible role in bringing innovative medical technology to market, this opportunity offers both technical depth and career-defining impact.What You’ll DoLead technical decision-making for catheter system architecture, including materials, tolerances, and early process development Design, execute, and analyze verification and validation strategies, including test method development Drive product development from concept through clinical readiness and commercialization within a regulated design control environment Conduct risk assessments using FMEA, tolerance analysis, and failure investigations Lead and contribute to design reviews and cross-functional technical discussions Translate clinical and user needs into engineering requirements, designs, and test strategies Partner with physicians and external advisors to inform product design and usability Collaborate with suppliers and manufacturing partners to ensure design feasibility and performance Present technical progress, key decisions, and milestones to senior leadership and stakeholders Contribute to continuous improvement of product development and manufacturability processes What You BringRequiredBachelor’s degree in Engineering (Mechanical or Biomedical preferred); advanced degree a plus 10+ years of experience in medical device design and development, including technical leadership responsibilities Deep expertise in catheter-based systems, including materials (polymers/metals) and bonding methods Experience developing Class III implantable medical devices Strong understanding of design controls, risk management, and regulatory requirements Proficiency with CAD tools (SolidWorks, Creo, or similar) Experience with design verification, testing, and documentation supporting regulatory submissions Strong analytical skills with tools such as Minitab, JMP, or similar Excellent communication skills and ability to influence across technical and non-technical stakeholders PreferredExperience with structural heart or transcatheter device development Familiarity with manufacturing scale-up and process validation Knowledge of catheter manufacturing processes (extrusion, braiding, hypotubes, etc.) Experience working in early-stage or emerging technology environments Background collaborating with contract manufacturers and external partners Experience mentoring engineers and contributing to team development Why This RoleBe part of a high-visibility program at a critical stage of development Work alongside experienced leaders with a track record of advancing medical technologies to market Gain end-to-end product development experience, including clinical and regulatory milestones Competitive compensation including base salary, performance incentives, and equity participation Comprehensive benefits package including medical, dental, vision, 401(k), and paid time off