Manufacturing Process Engineer (Madison, WI) | 08/06/26

Job Description Title:

Manufacturing Process Engineer Location:

Madison, WI Job Description:

• B.S. in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline
• 3+ years of manufacturing engineering experience in a regulated medical device or life sciences environment
• Hands-on experience authoring and executing

IQ/OQ/PQ

validation protocols

• Working knowledge of ISO 13485 and

FDA 21 CFR

Part 820 quality system requirements

• Proficiency in GD&T, technical drawing interpretation, and manufacturing process documentation
• Experience developing SOPs, work instructions, PFMEAs, and process control documentation
• Experience with precision medical device assemblies involving coaxial cable, small-gauge needle/cannula, thermocouple integration, or RF/microwave antenna construction
• Familiarity with EtO sterilization validation processes, bioburden testing programs, and packaging qualification (ASTM

F2097, ISO 11607

)

• Experience with controlled manufacturing environment (CME) or cleanroom assembly operations (ISO Class 7/8)
• Statistical analysis skills (Minitab or equivalent); SPC, process capability (Cpk), and DOE experience
• Exposure to multi-SKU / family validation strategies covering gauge, length, and configuration variants
• PFMEA, control plan, and risk management experience per

ISO 14971

Manufacturing Process Engineer1IQ or OQ or PQ ContractUnited States