Lumicity
Principal R&D Engineer
Lumicity Greater Minneapolis-St. Paul Area
Responsibilities:
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.
Required:
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.
Preferred:
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.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research and Engineering
Industries: Medical Equipment Manufacturing
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Responsibilities:
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.
Required:
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.
Preferred:
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.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research and Engineering
Industries: Medical Equipment Manufacturing
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