JOB DESCRIPTION: Note from client: Full-time through Nov 2026; part-time 20 hrs/week Dec 2026–Apr 2027, with possibility of extension/full-time projects.
Job Summary:
Seeking a Sr. Packaging Engineer to support the CST business unit (Enabling Technologies products) in a regulated medical device environment. The engineer will lead packaging activities related to manufacturing transfer, process validation, design verification, and packaging changes while ensuring compliance with FDA and EU MDR requirements.
Key Responsibilities:
Develop, execute, and document packaging test protocols and reports.
Support design verification (DV), validation activities, and manufacturing transfers.
Evaluate packaging changes and provide technical justification/rationale.
Collaborate with R&D, Manufacturing, Quality, and Supply Chain teams.
Manage packaging documentation and support GMP/quality requirements.
Ensure compliance with FDA, EU MDR, and medical device regulations.
Required Skills:
5–8 years of packaging engineering experience.
Experience in regulated medical device or similar industry.
Strong experience with:
Packaging design & testing
Manufacturing transfer
Process validation
Design verification
Technical documentation
Knowledge of FDA and EU MDR requirements.
Experience working cross-functionally with engineering, quality, and manufacturing teams.
Education:
Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.
Preferred Background:
Medical device packaging experience.
GMP documentation and validation experience.
Experience supporting product development and commercialization projects
Numbers & Facts
Location
Lafayette, CO
Salary
$55–$60 Per Hour
Skills
Biomedical Engineeringunmatched
Cross-Functionalunmatched
Design Verificationunmatched
Document Managementunmatched
Engineeringunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Process Validationunmatched
Product Developmentunmatched
Product Packagingunmatched
Product Supportunmatched
Product/Service Launchunmatched
Regulationsunmatched
Research & Development (R&D)unmatched
Supply Chainunmatched
Support Documentationunmatched
Technical Writingunmatched
Test Designunmatched
Testingunmatched
Validation Documentationunmatched
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