Senior Engineer

Akkodis is seeking a Senior Engineer for a Contract with a client in Rosemont, IL. This role requires deep expertise in medical device quality systems to effectively lead Technical Review Board (TRB) evaluations for cross‑functional change management.

Rate Range: $68/hour to $75/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Senior Engineer job responsibilities include:

• Lead, moderate, and document TRB meetings, ensuring structured, objective, and compliant evaluation of change proposals.

• Assess design intent, risks, usability, and regulatory impacts to ensure safety, quality, and compliance are maintained.

• Review and validate change‑related documentation including ECOs, design updates, risk assessments, deviations, and CAPAs.

• Collaborate with cross‑functional SMEs to clarify requirements, identify gaps or risks, and drive alignment and decision‑making.

• Ensure adherence to Medical Device QMS standards (ISO 13485, 21 CFR 820) and risk management per ISO 14971.

• Identify workflow inefficiencies and lead continuous improvement initiatives within TRB and change management processes.

Required Qualifications:

• Bachelor’s degree in engineering, Quality, Regulatory, Biomedical, or a related technical discipline.

• 6–8 years of experience in medical device quality, regulatory, or product engineering functions.

• Strong knowledge of Medical Device QMS standards such as ISO 13485, 21 CFR 820, and ISO 14971 for risk management.

• Proven experience facilitating cross‑functional technical reviews, driving decision‑making, and ensuring compliance in change management processes.

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 Shubham.Vasishtha@ akkodisgroup.com.

Pay Details: $68.00 to $75.00 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

Military connected talent encouraged to apply

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