Development Process Engineer
Job in
Maple Grove, Hennepin County, Minnesota, 55311, USA
Listed on 2026-02-28
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-02-28
Job specializations:
-
Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering
Job Description & How to Apply Below
- Candidates will work on Two projects related to Delivery systems. Develop processes for the systems that are used to deliver implants to the heart.
- Exposure to delivery system processes is required:
Reflow, Chipping and Curving. - Work closely with the R & D team. They will take the design and procure equipment. Develop processes, develop settings, qualify equipment in order to produce that design.
- Experience with Process validation, Equipment Qualifications, Writing manufacturing procedures, doing studies, writing samples and reports.
- Performed Process Development:
Hands on Manufacturing experience with operators. Clean room environment experience is required. - Experience with Writing and executing validations not just reading and reviewing validations.
- Experience writing manufacturing procedures (Working with operators on the line and t raining them on processes they need to follow to build the design that R&D has developed).
- Hands on experience when a candidate was assigned a line or product and have ensured deliverables are met in given timeline. Root Cause Analysis experience and have dealt with problems.
- Basic exp with Statistics in regards to the validations they have performed.
- Minitab experience is plus.
- Experience with plastic molding, and injection molding processes is strongly desired.
- Med device experience is strongly desired. May also consider a utomotive industry.
- Manufacturing or operations background.
- Familiarity with DFM, Design for Manufacturability, is a plus.
- Software exp:
Solidworks (CAD) for designing and tooling fixtures is plus.
- Minimum Bachelor's (Engineering degree – mechanical, biomedical, chemical)
- Minimum 3 years of experience is required however, manager prefers someone with 5+ years of med device manufacturing experience.
- Experience with IQ,OQ,PQ. Process Validation experience.
- Medical device Manufacturing industry experience.
- Equipment Validation and Molding experience.
- Worked with vendors ordering materials and equipment. Have strong communication skills.
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