• Location: Huntersville
• Type: Direct Hire
• Job #11633
• Salary: $150000

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.

Required Experience

• 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

Preferred Experience

• 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