Sr. Packaging Engineer (Medical Device)

Grove Technical Resources; Lafayette (CO); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Grove Technical Resources in Lafayette, CO is seeking a Sr. Packaging Engineer for medical devices to support manufacturing transfer, process validation, and design verification within the CST unit. You will drive ISO 11607 packaging validation, change control, and compliance with FDA 21 CFR Part 820 and EU MDR.

This is a full-time role through Nov 2026, then part-time (20 hrs/week) through Apr 2027, with potential for extension based on project needs.

Qualifications

• Bachelor's degree in Packaging, Mechanical, Biomedical or related field.
• 5-8+ years of relevant packaging engineering experience.
• Experience with regulated medical device packaging.
• Knowledge of ISO 11607 packaging validation and quality systems.

Responsibilities

• Support manufacturing transfer, process validation, and design verification for medical device packaging.
• Lead packaging validation activities and associated documentation.
• Ensure compliance with FDA 21 CFR Part 820 and EU MDR.
• Contribute to change control and continuous improvement initiatives.

Skills

Packaging Engineering

Manufacturing Transfer

Process Validation

ISO 11607

Change Control

FDA 21 CFR Part 820

Technical Documentation

Education

Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related field

Tools

3D Modeling

Job description

Hiring: Sr. Packaging Engineer (Medical Device)

Location: Lafayette, CO (4 days onsite, 1 day remote)

Duration: Aug 2026 - Apr 2027

Full-time through Nov 2026, then part-time (20 hrs/week) through Apr 2027, with the potential for a full-time extension based on project needs.

We are looking for a Sr. Packaging Engineer to support manufacturing transfer, process validation, and design verification activities for medical device products within the client CST business unit.

Key Skills:

• Packaging Engineering in Medical Device or other regulated industries
• Manufacturing Transfer & Process Validation (IQ/OQ/PQ)
• ISO 11607 Packaging Validation
• Change Control & Quality Systems
• FDA 21 CFR Part 820, GMP, and EU MDR Compliance
• Technical Documentation & Packaging Test Protocols

Preferred:

• 3D Modeling
• Cost Savings / Continuous Improvement Projects

Requirements:

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related field
• 5-8+ years of relevant packaging engineering experience.