Senior Process Engineer

Contract Process Engineer (Medical Device Manufacturing)

Duration: 6-month contract (high likelihood of extension)

Employment Eligibility Requirements:

• This position cannot support C2C (Corp-to-Corp) arrangements
• Candidates must be authorized to work in the United States without sponsorship now or in the future

We are seeking an experienced Process Engineer to support medical device manufacturing operations for a contract engagement with strong extension potential. This role will focus on process development, validation, and continuous improvement within a regulated manufacturing environment.

• Lead and support process development and validation activities, including test method validation and IQ/OQ/PQ
• Provide day-to-day manufacturing and equipment support to improve yield, quality, and throughput
• Drive continuous improvement initiatives using data analysis, SPC, DOE, and Lean methodologies
• Support equipment qualification, calibration, preventative maintenance, and fixture/tooling verification
• Partner cross-functionally with Quality, R&D, Operations, and Technical Services to resolve process issues
• Investigate and support nonconformances, deviations, and CAPAs to maintain compliance and validated state
• Develop and maintain manufacturing documentation including procedures, travelers, and validation reports
• Support process risk assessments and implementation of corrective actions

• Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field)
• 5+ years of experience in process or manufacturing engineering within medical device or regulated manufacturing
• Hands‑on experience with process validation, equipment qualification, and production support
• Working knowledge of ISO 13485 and 21 CFR Part 820
• Strong problem‑solving skills with experience using statistical and data‑driven tools
• Ability to work independently in a fast‑paced manufacturing environment

• Experience with joining processes (laser welding, resistance spot welding, or similar)
• Background supporting implantable or Class II/III medical devices
• Experience working in cross‑site or multi‑site manufacturing environments

This is an excellent opportunity for a contractor seeking a hands‑on engineering role with strong extension potential at a well‑established medical device manufacturing site in the northwest Minneapolis metro.

Mid‑Senior level

Contract

Manufacturing and Engineering

Medical Equipment Manufacturing