Highlights
Years’Experience Required: Typically 5 to 8 years of relevant packaging engineering experience, with a strong preference for experience in regulated medical device environments. This role offers the opportunity to work in a dynamic environment, supporting the CST business unit with a focus on Enabling Technologies products.
Numbers & Facts
| Location | Lafayette, CO |
| Industry | Staffing/Employment Agencies |
| Salary | $60 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
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
- 3D Modeling
- Applied Minitab analysis
- Cost savings analysis
- 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.
- 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
- 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 a strong preference for experience in regulated medical device environments.
- 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.
- As soon as possible, ideally within 1 to 2 weeks of candidate submission.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.