Summary:
We are looking for an experienced Project Engineer with a strong background in pharmaceutical, medical device, combination products, or other regulated industries. Roles & Responsibilities:
5+ years of experience in regulated industry environments (Pharma / Medical Device / Combination Products)
Strong expertise in Design History File (DHF) management and Design Control documentation
Experience with Use-Related Risk Analysis (URRA), Human Factors, and Risk Management
Knowledge of FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred
Experience supporting end-to-end product development from concept through market release
Strong project coordination, communication, facilitation, and stakeholder management skills
Lead planning and coordination of Use-Related Risk Analysis activities
Facilitate cross-functional collaboration with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams
Support documentation of hazards, use scenarios, failure modes, risks, and mitigations
Drive Design Control, Systems Engineering, and Quality by Design (QbD) activities
Support system architecture, requirements definition, traceability, risk assessments, and change management
Manage project schedules, risks, mitigation plans, and vendor communications
Education & Experience:
BS in Engineering, Science, or related discipline with 10+ years of relevant experience
MS with 8+ years of relevant experience
Ideal candidates will have experience with drug product delivery systems, combination products, human factors engineering, and regulated product development.
Numbers & Facts
Location
Lake County, IL
Skills
Biotech and Pharmaceuticalunmatched
Change Managementunmatched
Code of Federal Regulationsunmatched
Cross-Functionalunmatched
Document Managementunmatched
Drug Delivery Systemsunmatched
Drug Productsunmatched
FDA (Food and Drug Administration)unmatched
Healthcare Qualityunmatched
Human Factorsunmatched
ISO (International Organization for Standardization)unmatched
Manufacturingunmatched
Medical Equipmentunmatched
Organizational Skillsunmatched
Pharmacovigilanceunmatched
Product Developmentunmatched
Project Engineeringunmatched
Project Scheduleunmatched
Project/Program Coordinationunmatched
Project/Program Managementunmatched
Requirements Managementunmatched
Risk Analysisunmatched
Risk Managementunmatched
Schedule Developmentunmatched
Support Documentationunmatched
System Architectureunmatched
Systems Engineeringunmatched
Traceabilityunmatched
Vendor/Supplier Planningunmatched
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