Design Assurance Engineer

Job Title: Design Quality Engineer

Duration: 12+ Months (Possible extension)

Location: Maple Grove, MN 55369

Onsite Role

Responsibilities:

• Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet customer, and regulatory requirements.
• 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.
• 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.

Education/Experience:

• At least 3 years experience in the medical device industry
• 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)
• Functional understanding of risk controls including experience with updating and maintaining risk management documentation: DFMEA and Hazard Analysis