Design Engineering Lead – Medical Device R&D; Electro-Mechanical Capital Equipment
Listed on 2026-02-08
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Engineering
Product Engineer, Biomedical Engineer, Medical Device Industry, Systems Engineer
If you’re passionate about building complex medical technologies that make a real difference in patient care! Do you thrive at the intersection of hands-on engineering and technical leadership??? If so, this role was built for you.
We’re looking for a Design Engineering Lead to own the development of reusable, capital electro-mechanical medical devices
, guiding products from early concept through design freeze. In this highly visible role, you’ll lead multidisciplinary engineering teams, partner closely with cross-functional stakeholders, and drive innovation across the full New Product Development (NPD) lifecycle.
- Lead the design and development of electro-mechanical, reusable/capital medical devices from concept through design freeze.
- Own technical leadership for NPD programs, guiding engineers and designers through complex design challenges.
- Collaborate cross-functionally with sales, marketing, regulatory, quality, manufacturing, procurement, and engineering teams to ensure designs meet clinical, business, and regulatory needs.
- Develop and maintain design documentation
, including user needs, design inputs and outputs, test plans, risk analyses, and technical files. - Plan, execute, and evaluate testing at both the bench level and in clinical environments.
- Partner with vendors and contract manufacturers to develop, prototype, and test designs, ensuring smooth execution from concept to production readiness.
- Lead cross-functional project teams
, fostering a collaborative, inclusive, and high-performance engineering culture. - Manage suppliers and external resources
, including technical negotiations, schedules, and budgets. - Mentor and develop junior engineers, designers, and technicians
, providing technical guidance and career growth support. - Travel domestically and internationally to support development, supplier engagement, and NPD milestones.
- Bachelor’s degree in Mechanical Engineering (required).
- 10+ years of experience designing electro-mechanical capital equipment, ideally within regulated environments.
- Proven experience leading technical teams and influencing cross-functional partners.
- Strong ability to read, interpret, and create technical drawings and specifications
. - Excellent analytical, problem-solving, and systems-thinking skills
. - Comfort working through technical ambiguity in fast-paced development environments.
- Solid understanding of FDA and ISO medical device regulations
. - Willingness to travel domestically and internationally as needed.
- Master’s degree in Engineering or a related field.
- Prior experience in the medical device industry
, particularly with reusable or capital equipment.
This is an opportunity to shape next-generation medical technology
, influence design strategy, and lead engineering teams building sophisticated, real-world devices used in clinical settings. If you enjoy solving complex problems, mentoring engineers, and seeing your designs move from concept to clinical impact, you’ll find this role deeply rewarding.
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