Job 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.
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/ |
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.
Skills
- 3D Modelingunmatched
- Analysis Skillsunmatched
- Biomedical Engineeringunmatched
- Change Controlunmatched
- Commissioningunmatched
- Computer Systemsunmatched
- Design Verificationunmatched
- Engineeringunmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- ISO (International Organization for Standardization)unmatched
- Identify Issuesunmatched
- Laboratory Equipmentunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing/Industrial Processesunmatched
- Mechanical Engineeringunmatched
- Medical Equipmentunmatched
- Minitabunmatched
- Process Control Engineeringunmatched
- Process Validationunmatched
- Product Costingunmatched
- Product Packagingunmatched
- Product Positioningunmatched
- Quality Controlunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Research & Development (R&D)unmatched
- Salesunmatched
- Supply Chainunmatched
- System Validationunmatched
- Technical Supportunmatched
- Technical Writingunmatched
- Test Plan/Scheduleunmatched
- Testingunmatched
- Validation Documentationunmatched
- Validation Testingunmatched
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.
Free resume templatesFree resume builder
Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.
Free resume builder