Entegee · 6 hours ago
Process Engineer
Minneapolis, MN
Contract
Onsite
Senior Level
$50/hr - $65/hr
5+ years expEntegee is seeking a Senior Process Engineer for a 6+ month contract. This contractor will be responsible for leading the clinical build line and driving process development, validation, and commercialization for new products and equipment.
Information TechnologyStaffing Agency
Hiring Manager
Douglas Herling
Responsibilities
Lead clinical build line operations for new and existing medical device products
Own process development deliverables, including process characterization, optimization, and documentation
Develop, execute, and maintain process validation documentation (including GR&R, TMV, IQ, and related protocols/reports)
Characterize critical process parameters and establish process windows for electropolishing and related operations
Support new equipment introduction, including URS development, IQ activities, and integration into manufacturing
Collaborate with cross-functional teams to support New Product Development and commercialization activities
Drive completion of risk analysis activities such as FMEAs for new and existing processes
Support preparation for regulatory and quality audits related to process validation and manufacturing readiness
Qualification
Required
5+ years of medical device industry experience
BS in Engineering (Mechanical, Chemical, or Biomedical)
Hands-on process validation experience (e.g., IQ, OQ, PQ)
Experience supporting new equipment introduction and New Product Development (NPD)
Experience with electropolishing processes
Experience using Keyence and Sensofar measurement/inspection technology
Experience with GR&R and TMV studies
Experience with IQ documentation and execution
Experience performing or contributing to FMEAs
Preferred
Experience leading clinical build or pilot manufacturing lines
Experience characterizing processes and defining critical process parameters in a regulated environment
Experience supporting process scale-up from development to full commercialization
Experience with cleanroom manufacturing environments and medical device quality systems
Benefits
Medical
Dental
Vision
Term life insurance
Short-term disability insurance
Additional voluntary benefits
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay
Company
Entegee
Entegee is a staffing and recruiting company providing contract engineers and technical specialists.
201-500 employees
H1B Sponsorship
Entegee has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (1)
2022 (4)
2021 (8)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Bob Bolster
Chief Operating Officer
Company data provided by crunchbase