EntegeeSenior Process Engineer – Medical Device
6+ month contract
$50-$65/hour W2
Minneapolis MN - onsite
SummaryThis contractor will be responsible for leading the clinical build line and driving process development, validation, and commercialization for new products and equipment.
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
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
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
Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan.
Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.
These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit The Company will consider qualified applicants with arrest and conviction records.
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