Principal Mechanical Engineer; Medical Devices

Principal Mechanical Engineer (Medical Devices)

The Principal Mechanical Engineer will develop new products, redesign existing products, and conduct research and testing on product concepts related to medical devices. This role is a key member of the driving innovation, development, verification, and transfer to manufacturing in support of Merz business objectives.

The successful candidate must have experience in a medical device company and be fully familiar with regulatory and quality requirements across all stages of the product development lifecycle.

• Bachelor's degree in Mechanical, Industrial, Electrical Engineering or a related discipline
• 10+ years design and manufacturing experience in the medical device or component development industry
• Proven Design Controls experience, including design verification and validation
• Strong background in manufacturing and assembly process development and validation (IQ/OQ/PQ)

Hands-on experience with prototype development, test method development, and manufacturing scale-up Responsibilities

• Provide technical leadership of system features and functions for medical devices.
• Lead cross-functional engineering groups through collaboration and technical influence.
• Serve as subject matter expert in mechanical design, test methods, and system-level decisions.

• Lead advanced development projects; manage team members to ensure on-time execution.
• Deliver engineering analyses, feasibility studies, and detailed technical assessments.
• Provide broad mechanical engineering expertise across concept, design, verification, and transfer-to-manufacturing phases.
• Oversee design and process V&V activities in accordance with Design Controls.

• Develop, design, and test client concepts and solutions aligned with clinical, patient, and business needs.
• Collaborate with engineering and marketing teams on technical feasibility.
• Design and build test setups, fixtures, and prototypes for advanced development initiatives.

• Maintain compliant, accurate documentation following GDP and GMP standards.
• Author product requirements, specifications, and technical documentation.
• Plan, design, execute, and report system experiments aligned with feature development and the product roadmap.

• Create and execute test plans to prove and refine product designs.
• Perform performance calculations, design adjustments, and prototype evaluations.
• Validate test tools, fixtures, and setups per regulatory and quality expectations.

Ensure all testing complies with FDA, ISO, and internal quality system requirements.