Job Description

Job Title: R&D Packaging Engineer (Contract)

Location: Hybrid in Fremont, CA

Duration: 10+ Month W2 Contract

Overview:

We are seeking an experienced R&D Packaging Engineer to join our Sustaining Packaging team, supporting EU MDR implementation and sustaining activities for Neurovascular products at our Salt Lake City, UT and Cork, Ireland facilities.

Key Responsibilities:

• Design and develop packaging and labeling solutions for sterile and non-sterile medical devices from concept through commercialization
• Support EU MDR execution and implementation on SNV products
• Conduct design verification, shelf-life testing, and labeling development
• Collaborate with cross-functional teams including Quality, Regulatory, Clinical, Manufacturing, Supply Chain, and external partners
• Translate Voice of the Customer into improved packaging/labeling solutions
• Develop 3D models and artwork in partnership with drafting resources
• Ensure compliance with design controls and evolving global regulatory requirements
• Support audits, non-conformances, and CAPAs as needed
• Lead small-scale or co-manage large-scale packaging/labeling projects
• Mentor or supervise junior technical staff when needed

Basic Qualifications:

• Bachelor’s degree in Packaging, Industrial, Mechanical Engineering, or related technical field
• Minimum 3 years of experience in a regulated industry

Preferred Qualifications:

• Experience with medical device, biotech, or pharmaceutical packaging
• Knowledge of packaging design standards (ISO 11607, ASTM, ISTA)
• Familiarity with database-driven labeling systems and IFU development
• Proficiency in statistical analysis and interpreting test results
• Strong interpersonal, technical, and project management skills
• Demonstrated problem-solving and collaboration abilities
• Self-starter with the ability to manage a varied and fast-paced workload

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