Hybrid Principal Engineer, Quality

at ICU Medical

• Job title: Principal Engineer, Quality
• Job type: Full Time
• Experience level: Lead
• Salary: $123,750 - $177,375 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Lake Forest, United States

About the role

• Principal Quality Engineer leading post-market quality and compliance for infusion systems and temperature management products. Responsible for product quality improvements and regulatory compliance solutions.

Responsibilities

• Leads Post Market Risk Assessments of product issues to assess the need for Market Action
• Leads product performance investigations via failure analysis in individual complaints or through the evaluation of product-related trends (e.g., complaint, NCMR, SCAR)
• Leads the drafting of responses to regulatory enquiries associated with product performance
• Leads or participates in cross functional Complaint and CAPA Review Boards
• Owns or support product related CAPAs, as required
• Leads or participates in Quality projects and product risk file reviews, as required
• Leads and mentors, ensuring requirements associated with regulations and standards are met
• Effectively utilizes Quality tools to communicate recommendations to stakeholders
• Ensure readiness for any potential internal and/or external audits and inspections

Requirements

• Strong knowledge and experience in the application of global medical device regulations and standards, including 21 CFR 820/803/806, ISO 13485, ISO 14971, and IEC 60601
• Significant knowledge and experience in Failure Mode Analysis and Risk Management
• Expert in Quality Tools used in Quality Engineering investigations and Root Cause Analysis
• Ability to take a systems approach to understand the interactions between device components (i.e. hardware, software, consumables) when investigating product Quality issues
• Knowledgeable and experienced in applying statistical analysis to large/complex data sets
• A strong communicator experienced in interacting with auditors, customers and senior leaders
• A collaborative influencer who leads through change to drive product/process improvement
• Must be at least 18 years of age
• Bachelor’s degree in engineering (e.g., Electrical, Mechanical, Biomedical) or related STEM field from an accredited college or university is required
• Master’s degree preferred
• Medical device experience is required
• 10+ years of experience is required

Benefits

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement