A Design Assurance Engineer is needed for a leader in electronics, healthcare, and lighting in the Maple Grove, MN area. In this role, you will have the opportunity to support the transfer of Design Controls from a recent acquisition. You will be leading the remediation activity for risk management and supporting other transfer activities associated with the DHF transfer.
location: Maple Grove, Minnesota
job type: Contract
salary: $37.00 - 53.82 per hour
work hours: 8am to 5pm
- Leading the Risk Management File Remediation activities.
- This will include creation of new: Risk Management Plan, Product Hazard Analysis, Use FMEA, Design FMEA, Process FMEA, Risk Management Matrix, Risk Benefit Determination, Risk Management Report.
- Understanding the processes and intent of all aspects of the QMS related to Design Controls.
- Work with product development and sustaining teams and other Design Assurance QEs to assure compliance to the QMS.
- B.S. degree in Mechanical Engineering, Biomedical Engineering or related Science discipline.
- 2+ years' experience in Design Quality, Product Development or Operations Quality.
- 2+ years' experience in medical device industry.
- Working knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO14971, IEC62304).
- Working knowledge of the new product design and development in a regulated environment; preferably medical device.
- Working knowledge of the application of risk management; preferably to medical device development.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.