Process Development Engineer

Location:

Huntersville, North Carolina Type:
Direct Hire Job #11632

Salary: $90000

Location Type:
On-Site Responsible for developing, validating, and sustaining manufacturing processes and equipment used in medical device production. This role ensures products can be reliably transitioned from design to scalable production through process development, tooling/fixture design, validation (IQ/OQ/PQ), and cross-functional support. The engineer will also support production transfers, supplier manufacturing, and process improvement activities while ensuring compliance with FDA and ISO requirements.

Required Experience Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related field3+ years of experience in medical device or pharmaceutical manufacturing

Hands-on experience with process development, process flow design, and manufacturing documentation

Experience executing or supporting validation activities (IQ/OQ/PQ)
Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements

Experience developing or supporting process FMEAs and risk management activities

Ability to create and maintain work instructions, process documentation, and technical reports

Experience supporting production troubleshooting and manufacturing issue resolution

Proficiency in Microsoft Office and strong documentation skills

Preferred Experience

Experience with production transfers from R&D to manufacturing

Exposure to fixture/tooling design and manufacturing equipment development

Experience with CAD tools (Solid Works, Solid Edge, or similar)
Familiarity with Lean Manufacturing principles and continuous improvement

Experience working with suppliers or contract manufacturers

Knowledge of process capability analysis and validation protocols

Strong cross-functional collaboration with Quality, R&D, and Operations teams
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