Quality Engineer - Product Performance

About the Opportunity

JCW Group is partnering with an established medical device manufacturer to find a Principal Product Performance Trending Engineer for a 6-month contract. You'll be the technical authority on how the organization monitors product performance in the field, turning post-market data into sound, defensible trending strategies that protect patients and keep the quality system audit-ready.

This is a high-visibility role for an experienced engineer who enjoys applying statistics to real problems, building a clear rationale for technical decisions, and working with teams across the product lifecycle.

What You'll Do

• Design, refine, and maintain the strategies and thresholds used to monitor product complaints across a portfolio of medical devices
• Assess complaint history, product risk, lifecycle stage, and real-world usage to decide which monitoring approach fits each product
• Build and document the statistical and engineering rationale behind product-specific trending limits, and present and defend those decisions in reviews
• Run trending analyses, identify potential signals or unexpected shifts in performance, and drive investigation when concerns come up
• Periodically re-evaluate existing monitoring approaches so they stay current with product performance, risk, and regulatory expectations
• Work with R&D, Manufacturing, Clinical, Regulatory, Quality, and Complaint Investigation teams to align on monitoring decisions
• Prepare technical justifications, peer review records, and supporting documentation that meet quality system standards
• Help improve work instructions, procedures, and best practices for complaint monitoring and signal detection
• Support internal audits and regulatory inspections related to post-market surveillance
• Serve as a go-to resource on trending methodology, and mentor junior team members or lead cross-functional initiatives as needed

What You Bring

• Bachelor's degree in Engineering, Statistics, Quality, Life Sciences, or a related technical discipline
• 7+ years of experience in areas such as medical device quality, post-market surveillance, complaint handling or trending, reliability engineering, or product performance monitoring
• Hands-on experience building, evaluating, or maintaining complaint trending or signal detection methods
• A practical command of statistical concepts and how they apply to quality and field performance data
• Advanced Excel skills, including data manipulation, trend analysis, and reporting
• Sound technical judgment and a risk-based approach to complex problems
• Strong written and verbal communication, with the ability to explain technical reasoning to both technical and non-technical audiences

Nice to Have

• Medical device industry background
• Familiarity with FDA post-market surveillance expectations and EU MDR PMS requirements
• Experience with statistical process control, control charts, or other trend detection techniques
• A track record of writing engineering assessments, technical reports, or formal justifications
• Experience taking part in cross-functional reviews with Quality, Regulatory, Clinical, Manufacturing, or Product Development

Contract Details

• Duration: 6 months, with possibility of extension
• Location: Arden Hills, MN
• Schedule: Hybrid, 3 days onsite and 2 days remote