Lead Process Development Engineer
Job in
Huntersville, Mecklenburg County, North Carolina, 28078, USA
Listed on 2026-07-15
Listing for:
Interactive Resources LLC.
Full Time
position Listed on 2026-07-15
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Manufacturing Engineer, Validation Engineer -
Manufacturing / Production
Quality Engineering, Manufacturing Engineer, Validation Engineer
Job Description & How to Apply Below
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
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