Key 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.
Featured benefits
Medical insurance, Vision insurance, Dental insurance, 401(k)