Design Engineering Lead – Medical Device R&D (Electro-Mechanical Capital Equipment) jobs in United States
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Franssen Recruiting LLC · 16 hours ago

Design Engineering Lead – Medical Device R&D (Electro-Mechanical Capital Equipment)

Franssen Recruiting LLC is seeking a Design Engineering Lead to own the development of reusable, capital electro-mechanical medical devices. In this role, you will lead multidisciplinary engineering teams and drive innovation across the full New Product Development lifecycle.

Staffing & Recruiting
Hiring Manager
Jacquelyn Franssen
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Responsibilities

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

Qualification

Electro-mechanical designFDAISO regulationsTechnical leadershipMechanical Engineering degreeTechnical drawings interpretationAnalytical skillsSystems-thinking skillsProblem-solving skillsMentoring skillsCollaboration skills

Required

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

Preferred

Master's degree in Engineering or a related field
Prior experience in the medical device industry, particularly with reusable or capital equipment

Company

Franssen Recruiting LLC

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Franssen Recruiting is committed to aligning talent with their ideal careers and helping companies discover the most qualified candidates for their roles.

Funding

Current Stage
Early Stage
Company data provided by crunchbase