Mechanical Engineer – Medical Device Development

About the role

We are seeking a Mechanical Engineer to support the development of a next‑generation CPAP medical device in a regulated product development environment. The role focuses on early‑stage product development, risk assessments, requirements definition, and design validation to ensure product quality and readiness for key milestones.

Key responsibilities

• Develop and document part and component requirements for new product designs.
• Lead FMEA/DFMEA activities to identify, assess, and mitigate design risks.
• Support design verification and validation testing while documenting test results.
• Collaborate with cross‑functional engineering teams to ensure compliance with design and regulatory requirements.
• Maintain engineering documentation using SAP and Microsoft Office tools.
• Support product development activities leading up to design freeze and manufacturing readiness.

Required profile

• Bachelor’s degree in Mechanical Engineering.
• 3+ years of mechanical product development experience within the medical device industry.
• Strong experience with FMEA/DFMEA, design validation, and risk management.

Required skills

• FMEA / DFMEA
• Design validation
• Risk management
• SAP
• Microsoft Office
• CREO (preferred)