Staff Packaging Engineer
$140,000–$150,000 year
On-siteFranklin Lakes, New Jersey, United States
Job Summary
Serve as a subject matter expert in packaging design for Class II and III medical devices, pharmaceuticals, and combination products. Lead the design, development, and qualification of packaging systems, focusing on design for manufacturability principles while translating customer and regulatory requirements into engineering specifications. Manage multiple, complex, high-volume projects simultaneously and mentor other packaging engineers to drive innovation and standard processes. This role supports the commercialization of groundbreaking medical devices within a global leader in medical technology innovation, requiring deep knowledge of ISO standards, cGMP, and sterilization technologies.
Required Qualifications
- Bachelors degree in Packaging, Mechanical, Materials Engineering, or a related Science/Engineering field
- Minimum of 8 years of experience in packaging for medical devices, pharmaceuticals, and/or combination products
- Proven track record of technical leadership and delivering results
- In-depth knowledge of ISO-11607-1 and -2, ISO 13485, medical device packaging ASTMs, cGMP, and medical device validation methodology
- Proficiency in using solid modeling tools (SolidWorks preferred) and statistical analysis tools
- Experience with various medical device package designs and sterilization technologies
- Strong understanding of design for six sigma (DFSS) elements for packaging systems
Desired Qualifications
- Post-graduate degree
- Familiarity with DOT, IATA, and IMDG regulations for hazardous materials shipment
- V&V experience for drug containers and expertise in finite element analysis
- Knowledge of container closure USP standard & WHO guidelines
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