Senior Engineer, R&D Packaging

Senior Engineer, R&D Packaging

Fremont, CA

As a Senior Engineer, R&D Packaging, you will support the development, verification, and maintenance of packaging and labeling solutions for medical devices, partnering with cross-functional teams across the product lifecycle. This role offers the opportunity to work on both sustaining and improvement initiatives while ensuring compliance, product quality, and customer-focused packaging performance.

What You Will Do

• Develop packaging and labeling components for sterile and non-sterile medical devices, including artwork, instructions for use, and packaging specifications.
• Lead or support packaging and labeling projects from concept through commercialization, delivering project milestones on schedule.
• Author and execute design verification, transit testing, and shelf-life validation protocols and reports to support product requirements.
• Collaborate with quality, manufacturing, regulatory, clinical, marketing, supply chain, and R&D teams to drive project execution and maintain compliance.
• Evaluate Voice of Customer feedback, product performance data, and current processes to identify and implement continuous improvement opportunities.
• Support audits, non-conformances, corrective and preventive actions (CAPAs), and investigations related to packaging and labeling systems.
• Apply packaging design standards and regulatory requirements to ensure compliant packaging solutions and documentation.
• Mentor technical team members and provide technical guidance on packaging development, testing, and problem resolution.

What You Will Need

Required Qualifications

• Bachelor’s degree in Packaging Engineering, Industrial Engineering, Mechanical Engineering, or another related technical field.
• Minimum 2 years of experience in a highly regulated industry.

Preferred Qualifications

• Experience developing, testing, or supporting packaging and labeling solutions.
• Experience authoring technical documentation, including protocols, reports, specifications, or validation documentation.
• Experience in medical device, biotechnology, or pharmaceutical packaging development.
• Knowledge of packaging design and testing standards, including ISO 11607, ASTM, and ISTA.
• Experience with database-driven labeling systems, label development, or instructions for use (IFU) development.
• Experience with statistical analysis and interpretation of test results.

• $101,000 - $168,400 USD Annual