Principal Quality Engineer

Principal Product Performance Trending Engineer

Arden Hills, MN | Hybrid (3 days onsite, 2 remote) | 6-Month Contract with Possibility of Extension

Please note: This role cannot support C2C (Corp-to-Corp) arrangements. Candidates must be able to work on a W2 basis.

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

About JCW Group

JCW Group is a specialist life sciences recruitment partner that connects technical professionals with contract, project-based, and permanent opportunities across pharma, biotech, and medical device organizations. If you're interested in this role or would like to hear about similar opportunities, apply today or reach out directly to learn more.

This position is not open to C2C candidates.