Development Engineering

A Twin Cities MedTech client is seeking a direct hire R&D Engineer to support the development and optimization of a next‑generation transcatheter mitral valve replacement therapy. This role will focus on leveraging clinical feedback and procedural data to drive product enhancements, improve procedural efficiency, and optimize patient outcomes. The ideal candidate will combine strong engineering expertise with clinical insight, serving as a key liaison between engineering and clinical teams. This individual will translate physician and user feedback into product requirements while ensuring design intent aligns with procedural performance and real‑world clinical needs.
Key Responsibilities Analyze product performance, clinical outcomes, and anatomical data to identify opportunities for procedural improvements and product optimization.
Lead the collection, review, and evaluation of clinical case findings with cross‑functional teams including Clinical Affairs, Therapy Development, Regulatory Affairs, and Engineering.
Drive detailed assessments of procedural performance, device functionality, and clinical observations to support continuous product improvement.
Incorporate clinical learnings into procedural documentation, physician training materials, and best practices.
Plan and execute preclinical, simulated‑use, usability, and verification testing to evaluate device performance and user interaction.
Lead Human Factors Engineering (HFE) activities, including usability assessments and risk mitigation efforts.
Stay current on emerging technologies, competitive products, and clinical literature within structural heart and cardiovascular interventions.
Translate physician and clinical feedback into actionable engineering requirements and design specifications.
Support development and validation of test methods, fixture design, and execution of critical engineering testing.
Contribute to technical documentation, risk management activities, design history files, and regulatory submissions.
Qualifications: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline
At least 5 years of R&D, product development, or design engineering experience within the medical device industry.
At least 3 years of experience supporting structural heart, cardiovascular, or other Class III medical devices
Proficiency with CAD software such as SolidWorks or Creo/ProE.
Experience with anatomical imaging and modeling tools, including fluoroscopy, echocardiography, Materialise, Mimics, or similar platforms.
Knowledge of Systems Engineering and Human Factors Engineering methodologies.
Experience utilizing statistical analysis tools such as Minitab.
Familiarity with data management and data analysis techniques.

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