Design Quality Engineer III

Job Title:

Design Quality Engineer III Location:

Maple Grove, MN (Onsite)

Duration:

12-Month Contract (Potential Extension) Position Summary Boston Scientific is seeking an experienced Design Quality Engineer III to support Design History File (DHF) remediation and design control activities for sustaining medical device products. This role will focus on ensuring design documentation is complete, compliant, traceable, and audit-ready while supporting quality engineering initiatives across cross-functional teams. The ideal candidate will possess strong expertise in medical device quality systems, design controls, risk management, DHF maintenance, and regulatory compliance. This position offers the opportunity to play a key role in maintaining product quality and supporting remediation efforts that align with regulatory and business requirements. Key Responsibilities Support Design History File (DHF) remediation activities, including gap assessments, evidence collection, documentation reviews, and updates. Define remediation scope, assumptions, acceptance criteria, and identify additional documentation or testing requirements as needed. Develop, update, and maintain design control documentation, including: Design Inputs Design Outputs Design Reviews Verification & Validation Documentation Traceability Matrices Lead maintenance and updates of risk management documentation, including: Design Failure Mode and Effects Analysis (DFMEA) Hazard Analysis Risk Control Documentation Ensure end-to-end traceability between design requirements, risk controls, verification, and validation activities. Collaborate with R&D, Manufacturing, Regulatory Affairs, Quality, and Document Control teams to facilitate timely review and approval of remediation deliverables. Support audit and inspection readiness by organizing objective evidence and maintaining remediation records. Track project progress, maintain action item logs, identify risks, and communicate status updates to stakeholders. Apply structured problem-solving methodologies to address quality and compliance gaps. Drive assigned remediation activities to successful completion while maintaining compliance with quality system requirements. Required Qualifications Bachelor's Degree in Engineering or a related technical discipline. Minimum of 3 years of experience within the Medical Device industry. Strong understanding of Design Controls and Quality Systems. Hands-on experience creating, updating, and maintaining: Design History Files (DHF) Design Input Documentation Design Output Documentation Product Specifications Component Specifications Engineering Drawings Experience with Risk Management documentation, including: DFMEA Hazard Analysis Risk Controls Knowledge of product lifecycle documentation and design change management processes. Strong technical writing, analytical, documentation, and organizational skills. Preferred Qualifications Experience supporting DHF remediation projects. Familiarity with FDA Quality System Regulations (QSR) and applicable medical device standards. Experience supporting internal, external, and regulatory audits. Strong project coordination and cross-functional collaboration skills.

Pay:

$50.00 - $55.00 per hour

Work Location:

In person