Senior Packaging Engineer (Medtech)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Senior Packaging Engineer (Medtech): Developing sterile medical device packaging and labeling systems with an accent on validation documentation, material selection, and regulatory compliance. Focus on designing packaging from concept to manufacturing and ensuring adherence to ISO and ASTM standards.
Location: Hybrid (Wayne, NJ, US)
Salary: $115k - $125k
Company
provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.
What you will do
- Develop sterile medical device packaging and labeling systems, including heat sealing and transportation testing.
- Create detailed validation documentation, performance protocols, and accelerated aging studies.
- Prepare and improve specifications for packaging systems to ensure regulatory compliance.
- Provide technical support for in-house thermal transfer labeling and bar-coding systems.
- Coordinate the implementation of new tooling and fixtures for packaging operations.
- Train production operators and technicians on new equipment and processes.
Requirements
- B.S. in Packaging Engineering or a related technical degree.
- 5+ years of package engineering experience in the medical device industry.
- Experience with regulatory standards including ISO 11607-1&2, ASTM D4169, ISTA, and FED-X.
- Knowledge of packaging materials such as Tyvek, thermoformed trays, and films.
- Experience with healthcare labeling systems and GS1 bar-coding standards.
- Must be based in the US (Hybrid: Wayne, NJ).
Nice to have
- Proficiency in SolidWorks or other CAD-based drawing programs.
- Knowledge of statistical applications.
Culture & Benefits
- Comprehensive health, dental, and vision insurance.
- 401k plan with company match.
- Paid Time Off (PTO) and wellness initiatives.
- Flexible spending accounts for health and dependent care.
- Commuter benefits.
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