Medical Device Design Engineer

Akkodis is seeking a Medical Device Design Engineer for a client located in Maple Grove, MN. This is a 12-month contract Position. Ideally looking for a candidate with experience in the medical device manufacturing Industry

Pay Range: $45 - $55/hour;
The rate may be negotiable based on experience, education, geographic location, and other factors

• Supports Design History File (DHF) remediation initiatives by assisting with gap assessments, evidence collection, and documentation updates to close design control deficiencies for sustaining products.
• Supports remediation planning by helping define scope, assumptions, and acceptance criteria for use of legacy evidence; identifies when additional documentation, review, or testing may be needed and escalates to the remediation lead.
• Assists with creating and/or updating DHF content as applicable (e.g., design inputs/outputs, design review documentation, verification/validation evidence mapping, and traceability matrices) in accordance with internal procedures and regulatory requirements.
• Leads analysis and proactive upkeep of product risk management tools such as Hazard Analysis and DFMEA, including alignment of risk controls to remediated DHF documentation (inputs/outputs, verification, validation, labeling, and post-market information as applicable).
• Supports end-to-end traceability by helping reconcile relationships between design inputs, design outputs, risk controls, verification, and validation; documents discrepancies and supports closure of traceability gaps.
• Coordinates with cross-functional partners (e.g., R&D, Manufacturing, RA, Document Control) to route DHF remediation updates for review/approval and ensure documentation is completed, version-controlled, and available within required quality systems.
• Supports inspection/audit readiness for remediated DHFs by helping organize objective evidence, preparing summaries of remediation decisions/rationale, and assisting in responses to auditor questions under the direction of the remediation lead.
• Acts as an effective team member in supporting quality disciplines, decisions, and practices; may own assigned remediation tasks/deliverables and drive them to closure in alignment with the remediation plan.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including documentation and compliance gaps identified during DHF remediation.
• Supports remediation execution by maintaining assigned trackers/records (e.g., gap lists, action items, evidence inventories) and proactively communicating status, risks, and roadblocks to the remediation lead and functional stakeholders.

• At least 3 years of experience in the med device industry. MEE experience.
• Functional understanding of design controls including experience developing, updating, and maintaining product Design History Files and Design Input / Output documentations (Product Specification, Component Specifications, and Prints)
• Design controls and capital equipment/MEE experience are needed for the ideal candidate.
• Functional understanding of risk controls, including experience with updating and maintaining risk management documentation: DFMEA and Hazard Analysis
• Design controls experience - must have working knowledge of DFMEA, risk management documentation, and design documentation
• o Experience with only design testing and documentation of testing is not sufficient (I had seen a handful of candidates with this exact experience)
• Experience with medical electrical equipment/capital equipment
• Working knowledge of the following standards: IEC 60601, ISO 14971, ISO 13485, 21 CFR Part 820

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Punit Pathak at  or

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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