What are the responsibilities and job description for the Senior Packaging Engineer position at Grove Technical Resources, INC?
Job Title: Sr Packaging Engineer – Medical Device
Job Location: Lafayette, Colorado or North Haven CT (Fully Onsite)
Type: W2 contract
Duration: 12 months
Note: Only Medical devices experience is required.
Job Summary:
We are seeking a Packaging Engineer with strong experience in medical device packaging validation and regulatory compliance. This role will focus on ISO 11607 gap analysis, packaging remediation, and validation activities while collaborating with cross-functional teams to ensure high-quality and compliant packaging systems.
Key Skills / Must-Haves
Packaging Validation (IQ/OQ/PQ)
ISO 11607 (Part 1 & 2) – Gap Analysis & Compliance
Sterile Barrier Systems (SBS)
Medical Device / Pharma Packaging
Regulatory Compliance & GMP
ASTM / ISTA Testing Methods
Packaging Design & Process Development
Project Management & Cross-functional Collaboration
Key Responsibilities
Perform gap analysis on existing packaging systems per ISO 11607
Develop and execute packaging remediation & validation plans
Lead packaging system validations for medical devices
Support audits and ensure regulatory compliance
Define packaging specifications based on product and regulatory needs
Collaborate with Quality, Regulatory, and Engineering teams
Lead project meetings and provide updates to stakeholders
Support labeling and testing activities
Requirements
Bachelor’s in Packaging Science, Mechanical Engineering, or related field
5 years in medical device or pharma packaging
Strong knowledge of ISO 11607, ASTM, ISTA
Experience in validation, compliance, and packaging design
Familiarity with CAD/CAPE/TOPS (preferred)