Principal R&D Catheter Engineer

Lumicity Greater Minneapolis-St. Paul Area

• Lead product development activities for complex medical devices, from concept through verification, validation, and transfer to manufacturing.
• Define system architecture, specifications, and design inputs in collaboration with clinical, quality, and marketing teams.
• Provide technical expertise and mentorship to R&D engineers and cross-functional team members.
• Develop and execute test methods, verification and validation plans, and risk management documentation in compliance with ISO 13485 and FDA 21 CFR 820 requirements.
• Collaborate with manufacturing, quality, and regulatory teams to ensure design robustness, manufacturability, and regulatory compliance.
• Drive innovation through feasibility studies, prototyping, and evaluation of new materials, technologies, and processes.
• Prepare and present technical documentation and design reviews to leadership and external partners.
• Serve as a subject matter expert (SME) in one or more technical areas such as mechanical design, fluidics, electronics, software integration, or biomaterials.
• Support regulatory submissions (e.g., 510(k), PMA, CE Mark) with technical documentation and data.
• Champion continuous improvement of design processes, development tools, and best practices.

• Bachelor’s degree in Biomedical, Mechanical, Electrical, or related Engineering discipline.
• 10+ years of experience in medical device R&D, including full product development lifecycle.
• Proven track record of leading technical projects and cross‑functional teams.
• Strong understanding of design controls, risk management (ISO 14971), and quality systems (ISO 13485/FDA 21 CFR 820).
• Demonstrated ability to translate clinical and user needs into design requirements and validated solutions.
• Excellent communication, documentation, and leadership skills.

• Master’s or Ph.D. in Engineering or related field.
• Experience with Class II or Class III medical devices.
• Hands‑on experience with CAD, FEA, modeling, or embedded system development tools.
• Experience supporting regulatory submissions and design history files (DHFs).
• Familiarity with human factors engineering and usability studies.

• Mid‑Senior level

• Full‑time

• Research and Engineering

• Medical Equipment Manufacturing

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