Senior Design Quality Engineer

About the Role

The position will require you to utilize extensive quality knowledge and technical skills to help support and execute integration activities, for a compliant and efficient integration of BSC design controls, and related QMS deliverables. You will work in a highly collaborative environment, with a team of quality engineers focused on product sustaining support of the integration. This position will be located at the Maple Grove, MN site.

Responsibilities

• Lead Design Assurance activities throughout the product lifecycle, ensuring compliance with Design Control requirements, quality system procedures, and applicable regulatory standards.
• Partner with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, Operations, and Marketing, to ensure quality objectives are integrated into product development and sustaining engineering activities.
• Establish, implement, and maintain Design Controls based on Risk Management, customer needs, intended use, and manufacturing considerations.
• Develop, review, and maintain Design History File (DHF) documentation, including Design Inputs, Design Outputs, specifications, drawings, traceability matrices, and design review documentation.
• Lead and maintain product Risk Management activities, including Risk Management Plans, Hazard Analyses, Design FMEAs, Fault Tree Analyses, Task Analyses, and Risk Management Reports in accordance with ISO 14971 and applicable company procedures.
• Provide Design Quality oversight for verification, validation, and usability engineering activities to ensure compliance with internal procedures and applicable regulatory requirements, including IEC/ISO 62366 where applicable.
• Evaluate design changes throughout the product lifecycle, ensuring proposed changes are appropriately analyzed, risk assessed, documented, verified, validated, approved, and implemented in accordance with Design Control requirements.
• Support sustaining engineering activities by evaluating product, process, packaging, and manufacturing changes to ensure continued compliance with quality and regulatory requirements.
• Assess post-market information, including complaints, nonconformances, and product performance data, to evaluate product risk, identify trends, and support risk-based decision making.
• Apply structured problem-solving methodologies (e.g., 5 Whys, DMAIC, Fishbone, Is-Is Not) to investigate quality issues, identify root cause, implement effective corrective actions, and drive continuous improvement.
• Develop technical documentation supporting Design Assurance activities, including protocols, reports, technical justifications, risk assessments, engineering evaluations, and quality plans.
• Ensure product development activities comply with applicable regulations and standards, including FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, ISO 14971, and other applicable global regulatory requirements.
• Provide quality guidance during design reviews, risk reviews, and cross-functional project meetings, serving as the Design Quality representative on product development teams.
• Lead or support quality planning activities, including development of Quality Plans, project quality deliverables, and project tracking to ensure milestones and regulatory commitments are achieved.
• Evaluate the effectiveness of quality systems, processes, and product development practices, identifying opportunities to improve compliance, efficiency, and product quality.
• Collaborate with project managers and functional leaders to establish priorities, manage deliverables, and ensure timely execution of Design Quality activities.
• Partner with cross-functional teams to identify and implement value improvement and continuous improvement initiatives that enhance product quality, compliance, manufacturability, and business performance.
• Support internal, customer, and regulatory audits by preparing documentation, presenting objective evidence, responding to audit observations, and implementing corrective actions as required.
• Proactively identify quality, compliance, and project risks, communicate findings to stakeholders, and drive timely resolution through appropriate risk mitigation strategies.
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