Design Quality Engineer (Medical Device) - Akkodis : Job Details

Akkodis is seeking a Design Quality Engineer for a 12+ Contract position with a client located in Maple Grove, MN

Pay Range: $45/hr - $46/hr (The rate may vary based on experience, education, geographic location, and other factors.)

Position Responsibilities

This is an exciting opportunity to participate in the quality assurance of our medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division.

The Design Quality Engineer II will support application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction.

Key Responsibilities

• Ownership of design change projects including scoping, assessment, and implementation.
• Develop, update, and maintain Design History File and Design Input / Output documentation
• Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Qualifications

• 3-5 Years with BS. Degree must be clearly stated on resume.
• Bachelor's degree in mechanical, electrical, or biomedical engineering, highly preferred
• Experience with design control, risk management, and medical device standards compliance
• Experience with corrective and preventive action

If you are interested in this Design Quality Engineer job in Maple Grove, MN, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com. If you have questions about the position, please contact Sunny Kumar at [email protected].

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an 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. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

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The Company will consider qualified applicants with arrest and conviction records by 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