Manufacturing Process Engineer

Title:  Manufacturing Process Engineer

Location: Madison, WI

Implementation Partner - HCL America

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