- Location: Huntersville
- Type: Direct Hire
- Job #11633
- Salary: $150000
Location Type: On-Site
The Lead Process Engineer will lead the development, validation, transfer, and optimization of manufacturing processes supporting medical device products. This individual will serve as a technical leader responsible for process characterization, risk management, equipment qualification, manufacturing scale-up, and continuous improvement initiatives across internal manufacturing operations and external suppliers.
The ideal candidate will have extensive experience in regulated manufacturing environments and a proven track record of successfully bringing processes from development through commercial production while ensuring compliance with FDA and ISO standards.
- Bachelor’s Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related technical discipline
- 10+ years of process engineering experience within medical device, pharmaceutical, or other FDA regulated environment
- Working knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements
- Strong experience with process development, characterization, validation, and continuous improvement
- Hands-on expertise executing IQ/OQ/PQ process validations and authoring validation protocols and reports
- Experience leading Process FMEA activities, risk assessments, and root cause investigations
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- Experience supporting manufacturing transfers, supplier process development, and new product introductions
- Strong analytical and statistical problem-solving skills with experience utilizing Lean Manufacturing and Six Sigma methodologies
- Ability to troubleshoot complex manufacturing processes and implement sustainable corrective actions
- Sterilization and packaging validation experience
- Minitab proficiency and process capability analysis
- Fixture and tooling design experience
- Lean Six Sigma certification
- Experience with Microsoft Dynamics 365 or similar ERP systems
