Senior Medical Device Packaging Engineer: Transfer & Validation

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

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.