Engineering Manager
Listed on 2025-12-15
-
Engineering
Manufacturing Engineer, Biomedical Engineer, Quality Engineering, Medical Device Industry
Recruiter - Executive Search | Diagnostics | Medical Device | Life Science | Nutraceutical | Talent Expert for Sales, Marketing, Clinical Affairs…
We are recruiting for a Medical Device Company that is dedicated to developing innovative medical technologies that improve patient outcomes and transform healthcare delivery. Their team is driven by a shared mission: creating safe, effective, and life-changing devices that clinicians trust and patients rely on. The company is expanding, they're seeking an Engineering Manager to lead our growing engineering team.
About the Role:
The Engineering Manager will play a key leadership role in guiding multidisciplinary engineering teams through the full product development lifecycle—concept, design, testing, verification/validation, regulatory submission, and manufacturing transfer. This individual will be responsible for strategic technical direction, people leadership, and ensuring the timely delivery of high-quality, compliant medical devices.
What You’ll Do
- Lead and mentor a team of mechanical, electrical, software, and systems engineers.
- Drive project execution across development phases following ISO 13485
, IEC 60601
, and other relevant standards. - Collaborate with Quality, Regulatory, Clinical, and Manufacturing teams to ensure robust design and compliance.
- Oversee risk management activities including ISO 14971 compliance and design reviews.
- Manage engineering processes including design controls, documentation standards, and change management.
- Lead activities including ECR/ECO processes, equipment and production line qualification, and writing/maintaining work instructions (WI).
- Manage project timelines, budgets, and resource planning.
- Partner with leadership to define product roadmaps and technology strategy.
- Promote a culture of innovation, accountability, and continuous improvement.
Required Qualifications
- BSc. in Mechanical Engineering or a related engineering degree.
- Proven engineering experience of minimum 5 years.
- Experience using CAD.
- Familiarity with GMP
, ISO standards
, and FDA regulatory requirements
. - Strong understanding of medical device design controls and risk management processes.
- Team player with excellent communication and collaboration skills.
- Results-driven with a strong sense of urgency.
- Self-directed, proactive, and highly organized.
Why Apply?
- Opportunity to directly impact products that improve lives.
- Competitive compensation, equity opportunities, and comprehensive benefits.
- Career growth in a rapidly scaling company.
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Engineering, Management, and Manufacturing
Industries:
Medical Equipment Manufacturing, Manufacturing, and Hospitals and Health Care
Location:
Naples, FL
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