Job Summary
We are seeking a seasoned Medical Device R&D Leader to spearhead the development of cutting-edge medical devices. As a key member of our research and development team, you will be responsible for leading technical development efforts from concept to commercialization, mentoring junior engineers, and collaborating across functions to drive innovation.
* Develop and implement design strategies for Class II/III medical devices, ensuring compliance with FDA and ISO 13485 regulations.
* Create and maintain accurate design history files (DHF) and perform risk analysis (FMEA), verification & validation (V&V), and root cause analysis.
* Collaborate with clinical, regulatory, manufacturing, and quality teams to ensure successful product development and launch.
* Stay up-to-date with technological advancements and bring forward innovative ideas and solutions to drive business growth.
* Provide technical guidance and mentorship to junior team members, fostering a culture of excellence and knowledge sharing.
Requirements
* Bachelor's or Master's degree in Mechanical, Biomedical, or related Engineering field.
* Minimum 4 years of experience in medical device R&D, with a strong background in design controls, regulatory requirements, and quality systems.
* Proven track record of successfully developing and launching medical devices from concept to market.
* Proficiency in CAD tools (SolidWorks or equivalent) and statistical tools (Minitab, JMP).
* Excellent problem-solving, communication, and collaboration skills, with the ability to work effectively in a fast-paced environment.
What We Offer
* A competitive compensation package, including bonus and pension benefits.
* A comprehensive healthcare plan, promoting employee well-being and work-life balance.
* Ongoing training and professional development opportunities, supporting career advancement and personal growth.
* A dynamic and inclusive company culture, valuing diversity, equity, and inclusion.
Join Our Team
If you are a motivated and experienced Medical Device R&D professional looking for a challenging opportunity to drive innovation and growth, we encourage you to apply.