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