2 дня назад
Packaging Engineer II – CST – Lafayette, CO or Fort Worth, TX (Onsite)
80 000 - 120 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Packaging Engineer II (Medical Device Packaging): Developing, validating, and sustaining packaging systems for sterile medical devices, reusable instruments, and capital equipment with an accent on product protection, sterility, manufacturability, and regulatory compliance. Focus on packaging validation through sterilization, distribution, storage, and shelf life, risk mitigation, root-cause analysis, and cross-functional commercialization.
Location: Lafayette, Colorado, or Fort Worth, Texas, United States; onsite four days per week with less than 10% travel.
Salary: $80,000–$120,000 per year, plus eligibility for a short-term incentive plan.
Company
develops healthcare technologies and medical devices focused on improving patient outcomes, including spinal implants, surgical navigation, robotic guidance, imaging, and data-driven planning platforms.
What you will do
- Lead packaging engineering activities for new product development and sustaining projects.
- Design, develop, evaluate, and validate packaging systems and materials for sterile medical devices, reusable instruments, capital equipment, and related components.
- Create packaging specifications based on product requirements, sterilization methods, distribution environments, cost, and FDA, ISO, ASTM, and other applicable standards.
- Plan and execute validation protocols, testing, data analysis, and reporting across sterilization, distribution, storage, and shelf-life conditions.
- Lead design reviews, risk assessments, and cross-functional meetings with R&D, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and suppliers.
- Investigate packaging issues, perform root-cause analysis, implement corrective and preventive actions, and drive improvements in performance, sustainability, quality, manufacturability, and cost.
Requirements
- Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Materials Science, or a related engineering field with at least 2 years of relevant experience, or a relevant master’s degree with no experience required.
- Experience creating and maintaining packaging specifications, drawings, bills of materials, validation reports, and engineering change documentation.
- Knowledge of packaging development, validation strategies, risk management, and quality system requirements.
- Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is not available for roles below Principal level.
- For degrees earned outside the United States, the degree must satisfy the stated U.S. regulatory requirements.
Nice to have
- Experience leading packaging development projects or serving as a technical lead on cross-functional engineering teams.
- Hands-on experience with sterile barrier systems and ethylene oxide, gamma irradiation, or electron-beam sterilization.
- Working knowledge of ISO 11607, ASTM, and ISTA distribution testing.
- Experience developing packaging for sterile medical devices and capital equipment.
- Experience with Creo, Pro/ENGINEER, or SolidWorks.
Culture & Benefits
- Onsite collaboration four days per week with a focus on cross-functional engineering work.
- Health, dental, and vision insurance, health savings and flexible spending accounts, life insurance, and disability benefits for eligible regular employees.
- Paid time off, paid holidays, 401(k) contributions and matching, employee stock purchase plan, and employee assistance program.
- Tuition assistance or reimbursement and access to a global well-being program.
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