Req ID: HCR0003122 Title: Principal Mechanical Engineer (Medical Devices) Location: 6501 Six Forks Rd. Raleigh, NC 27615 Pay Rate: $55-$65/HR on W2 Overview 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 lifecycl Minimum Qualifications
- 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 1. Technical Lead
- 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.
- 2. Mechanical Engineering & Project Leadership
- 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.
- 3. Innovation
- 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.
- 4. Documentation
- 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.
- 5. Test Methods
- 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. Kindly share your resume with answers: Q1: How many years of exp in design and manufacturing experience in the medical device or component development industry Q2: How many years of exp in Design Control experience including design and process verification and validation Q3: How soon you are ready to start and what is your present salary