Contract Process Engineer (Medical Device Manufacturing) Location: Northwest Metro – Minneapolis, MN 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.
Key Responsibilities:
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
Required Qualifications:
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
Preferred Experience:
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.
