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Design Assurance Engineer
Contract: Plymouth, Minnesota, US
Salary Range: 50.00 - 55.00 | Per Hour
Job Code: 364064
End Date: 2025-08-28
Days Left: 26 days, 11 hours left
Summary:
- A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system.
- Lead completion of risk management and risk analysis including FMEA.
- Devise design verification and design validation plans for products based on performance specifications and risk analysis.
- Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
- Reviews Engineering Change Orders, as required.
Responsibilities:
- This role involves focus on design assurance, including reviewing print and design documentation and analyzing collected data.
- The position is more mechanically focused than software-oriented.
- As part of the project team, you will be involved in in-house manufacturing and transitioning to external manufacturing and suppliers.
- Will contribute to the larger project team, focusing on the integration of production process control with design control; Going through production process control and how it is tied to design control.
- Someone to support production of a subassembly for ablation catheters used in electrophysiology (EP).
Must Haves:
- BS/BE degree required, Mechanical, Biomedical, Material related degree preferred.
- Candidates with approximately 5-7 year of experience in product development space in medical device.
- Some experience in supplier quality and disposable medical device preferred.
- Design documentation, changer order experience.
- Windchill is required. Used for Change control, CAPA, QMS.
Pay Range:
- $50-55/Hr
Job Requirement
- Change control
- CAPA
- QMS
- Windchill
- dFMEA
- electrophysiology
- catheters
- ablation
- Disposable Medical Devices
- design assurance
- design documentation
- design control
- Design Assurance
- FMEA
- Supplier Quality
- Medical Device
- GMP
- ISO 13485
Reach Out to a Recruiter
- Recruiter
- Phone
- Sanjay Rawat
- sanjay.rawat@collabera.com
Apply Now
Apply Now
