Principal Design Quality Engineer - IO&E Quality Systems and Design Post-Market Surveillance Lead

Boston Scientific • Maple Grove, MN

5d • $102,100 - $194,000 • Hybrid

About The Position

The IO&E Divisional Quality Systems & Design Post-Market Surveillance Lead will serve as the divisional leader responsible for integrating Post-Market Surveillance, Quality Management Review (QMR), Quality Systems governance, and Guardian sustainability activities across the IO&E portfolio. This role will ensure product performance data, complaint trends, risk management activities, quality system health, and management review processes are effectively connected to support proactive quality management, informed decision-making, and continuous improvement. The individual will partner closely with Design Assurance, Complaint Investigations & Trending, Data Analytics, Quality Systems, Regulatory Affairs, Medical Safety, and R&D to drive effective monitoring of product and quality system performance and support executive quality governance.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• Minimum of 8 years of experience in Medical Device Quality, Design Assurance, Post-Market Surveillance, Quality Systems, or a related regulated environment.
• Demonstrated ability to lead effectively across a broad set of cross-functional partners and diverse functions in a highly matrixed environment.
• Proven ability to apply systematic problem-solving methodologies to identify and resolve quality issues.

Nice To Haves

• Experience with PMS Plans, PSURs, complaint analytics, product performance monitoring, and quality system governance.
• Experience supporting site or divisional Quality Management Review processes.
• Experience developing executive-level dashboards, metrics, and quality reporting.
• Strong understanding of Design Controls, Risk Management, and post-market regulatory requirements.
• Experience leading quality remediation, quality system transformation, or continuous improvement initiatives.

Responsibilities

• Support Arbor Lakes site-level QMR activities as the primary IO&E Quality representative, including coordination of divisional inputs and follow-through on assigned actions.
• Own the IO&E divisional QMR process, including development of Quality Management Reports, executive review materials, dashboards, and key quality metrics that provide a holistic view of product performance, quality system health, and Guardian sustainability.
• Lead integration of product performance, complaint, risk management, quality system health, and Guardian sustainability metrics into Quality Management Review processes and executive reporting to support proactive identification and management of quality risks.
• Partner with cross-functional teams to identify, escalate, and drive resolution of systemic quality and compliance risks.
• Monitor effectiveness of quality system improvements, support inspection readiness activities, and ensure management review actions are completed and sustained.
• Serve as the divisional Design PMS lead and subject matter expert, with Design Assurance accountability for PMS Plans, PSURs, post-market risk assessment, and integration of post-market information into product risk management.
• Partner with Complaint Investigation & Trending and Data Analytics as key providers of complaint data, trend analyses, and emerging signals; lead the Design Assurance evaluation of those inputs with Regulatory Affairs, Medical Safety, and R&D to determine required PSUR, risk management, design, or other product lifecycle actions.
• Drive growth and maturity of Design PMS practices by ensuring post-market learnings are systematically incorporated into Risk Management, Design Controls, CAPA activities, and continuous improvement throughout the product lifecycle, including Guardian-related surveillance and remediation activities.
• Provide training and guidance to Design Assurance team to drive consistent application of post-market surveillance processes and effective utilization of post-market data.
• Monitor the effectiveness of Design PMS integration across the division, identify capability gaps, and lead improvements that strengthen how Design Assurance understands and applies post-market information within PSUR and risk management processes.

Benefits

• Relocation assistance is not available for this position at this time.
• Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal