Design Quality Assurance Engineer

Akkodis is seeking a Design Quality Assurance Engineer for a Contract job with a client in Maple Grove, MN(Hybrid). You will support verification and validation activities and maintain product risk management documentation while collaborating with cross-functional teams to ensure compliance and product quality.

Rate Range: $50/hour to 58/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

 

Design Quality Assurance Engineer job responsibilities include:

• Support and document design verification, validation, and usability testing activities for medical devices.

• Develop and maintain risk management documentation, including hazard analyses, FMEAs, and fault trees, in compliance with ISO 14971.

• Collaborate with R&D, software, systems, and clinical engineering teams to ensure design quality throughout the product lifecycle.

• Maintain and update Design History Files and design input/output documentation.

• Lead root cause investigations and support resolution of quality issues through structured problem-solving.

• Ensure compliance with regulatory standards (e.g., FDA, IEC 62304, ISO 13485) and support regulatory submissions.

 

Desired Qualifications:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related field.

• Minimum 2 years of experience in design assurance, quality engineering, or new product development within a regulated industry.

• Strong knowledge of ISO 14971 risk management and experience with design verification and validation processes.

• Familiarity with medical device regulations and standards such as IEC 62304, IEC 60601, and experience working with software or capital equipment.

 

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Punit.Pathak@akkodisgroup.com

Pay Details: $50.00 to $58.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.akkodis.com/en/us/candidate-privacy-policy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance