Mechanical Engineer

We are seeking a Mechanical Engineer to support the development of a next-generation CPAP medical device within a regulated product development environment. This role will focus on early-stage product development, design risk assessments, requirements development, and design validation activities to ensure product quality and readiness ahead of key project 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.

Qualifications:

• 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.

• Proficiency with SAP and Microsoft Office.

• CREO experience and knowledge of CPAP or similar medical devices is a plus.