Sr Packaging Engineer

8-month contract with a potential for extension in Lafayette, CO. W2 contract, no PTO, no benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

About the role

Senior Packaging Engineer supporting the CST business unit. This contractor will lead and support packaging-related work tied to manufacturing transfer, process validation, and design verification in a regulated medical device environment.

Responsibilities

• Collaborate with R&D, manufacturing, quality, and supply chain teams.
• Develop and execute packaging test protocols and reports.
• Support validation and verification documentation.
• Evaluate packaging changes and associated technical rationale.
• Ensure compliance with FDA and EU MDR expectations.
• Design, develop, and test a wide variety of containers used for the protection, display, and handling of products.
• Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required (e.g., resistance to moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering).
• Design package exteriors considering product identification, sales appeal, aesthetic quality, printing, and production techniques.
• Manage documentation and/or coordinate Good Manufacturing Practices (GMPs).
• Support prototype line development in manufacturing facilities/plants.

Requirements

• Change control of medical devices.
• Equipment commissioning/qualification.
• Process validation.
• Computer System Validation (CSV).
• Experience with manufacturing, packaging, and laboratory equipment.
• Technical troubleshooting experience.
• Quality/process control/assurance of medical devices.
• Design and development of a packaging system for terminally sterilized medical devices as per ISO 11607-1 (requirements for materials, sterile barrier systems, and packaging systems) and corresponding ASTM and ISTA standards.
• Validation of processes for packaging medical devices that are terminally sterilized as per ISO 11607-2 (validation requirements for forming, sealing, and assembly processes).
• Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices.
• Experience in equipment IQ and process validation lifecycle (from process characterization, OQ to PQ).

Qualifications

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.
• Typically 5 to 8 years of relevant packaging engineering experience, with strong preference for experience in regulated medical device environments.

Top 3 technical skills

• Packaging engineering experience in regulated medical device or other regulated industries.
• Manufacturing transfer, process validation, and design verification experience.
• Working knowledge of FDA and EU MDR requirements, including technical documentation and justification support.

Nice-to-have skills

• 3D modeling.
• Applied Minitab analysis.
• Cost savings analysis.
• Sterile barrier testing.

Pay

$55.00 - $65.00/hr.