Lead Process Development Engineer

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. 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