Sr Packaging Engineer - Exempt

We are seeking a dedicated and experienced professional to join our team in Lafayette, CO. This role offers the opportunity to work in a dynamic environment, supporting the CST business unit with a focus on Enabling Technologies products. The position is full-time through November 2026, transitioning to part-time through April 2027, with the potential for a return to full-time based on project needs.

Must Have:

• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Technical experience (Troubleshooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices
• Design and development of a packaging system for terminally sterilized medical devices as per ISO 11607-1 and corresponding ASTM and ISTA standards
• Validation of processes for packaging medical devices as per ISO 11607-2
• Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
• Experience in equipment IQ
• Process Validation Lifecycle (from process characterization, OQ to PQ)
• 5 years experience with a BS in Packaging or related engineering field or 3 years with MS
• Sterile Barrier Testing

Nice to Have:

• 3D Modeling
• Applied Minitab analysis
• Cost savings analysis

Responsibilities:

• Lead and support packaging-related work tied to manufacturing transfer, process validation, and design verification in a regulated medical device environment.
• 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 for product protection, display, and handling.
• Determine packaging specifications considering product nature, cost limitations, legal requirements, and protection needs.
• Design package exteriors considering product identification, sales appeal, aesthetic quality, and production techniques.

Technical Skills Required:

• 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

Education Required:

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.

Years’ Experience Required:

• Typically 5 to 8 years of relevant packaging engineering experience, with a strong preference for experience in regulated medical device environments.

Work Schedule:

• Full-time support at 40 hours per week through November 2026, then part-time (20 hours per week) through April 2027.
• Onsite 4 days per week, with one day remote allowed.

Interview Timeline:

• As soon as possible, ideally within 1 to 2 weeks of candidate submission.