ICU Medical

Principal Engineer, Quality

ICU Medical

full-time

Posted on:

Location Type: Hybrid

Location: Lake Forest • Illinois • United States

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Salary

💰 $123,750 - $177,375 per year

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Failure Mode AnalysisRisk ManagementRoot Cause AnalysisStatistical AnalysisQuality EngineeringProduct Performance InvestigationPost Market Risk AssessmentCAPA ManagementRegulatory ComplianceQuality Tools
Soft Skills
Strong CommunicationCollaborationInfluencingLeadershipMentoringStakeholder EngagementChange ManagementProblem SolvingInterpersonal SkillsTeamwork
Certifications
Bachelor’s Degree in EngineeringMaster’s Degree in EngineeringISO 13485 CertificationIEC 60601 Certification21 CFR 820 Certification21 CFR 803 Certification21 CFR 806 Certification