Engineering Manager

3 giorni fa

Greater Naples Metropolitan Area, Italia Next Level Impacts A tempo pieno 80.000 € - 120.000 € all'ano

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.
  • Work in a supportive, mission-driven environment.
  • Competitive compensation, equity opportunities, and comprehensive benefits.
  • Career growth in a rapidly scaling company.

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