R&D Product Development Packaging Engineer

Location: San Diego, CA • 12-month contract on W2 • 40 hours/week • $30–40/hr • 1st shift

About the Role

The R&D Packaging Engineer III will drive the commercialization of new products and design changes for current products through development, qualification, and launch phases. This role requires deep technical expertise in medical-device packaging, including concept development, device verification and validation, and root-cause analysis. The position is highly collaborative, involving cross-functional teams to plan, develop, modify, implement, and support Infusion Preparation and Delivery (IPD) products. More than 80% of the time will be spent in the lab and office in San Diego or Brea, CA.

Responsibilities

• Lead R&D deliverables throughout the medical-device design-control process for intravenous infusion sets and connection devices.
• Collaborate within a cross-functional team to plan, develop, modify, implement, and support IPD products using rigorous engineering practices.
• Engineer robust products through a strong understanding and application of engineering fundamentals and DFSS principles and/or Six Sigma tools (e.g., Kaizen, process improvement).
• Develop technical plans and guide the team to establish design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify and validate subsystems and systems, transfer designs alongside Manufacturing and Operations, and provide design documentation to support global regulatory filing strategies.
• Execute design verification testing to confirm design outputs meet design input requirements.

Requirements

• BS in Mechanical Engineering, Materials Engineering, or Biomedical Engineering.
• 5 years of work experience, or 3 years plus an advanced degree, in the development of ISO 11607, ASTM Packaging Standards, and Medical Device Packaging Design.
• Proficiency with SolidWorks or equivalent CAD tools.
• Critical thinking with the ability to work with moderate guidance in your area of expertise.
• Ability to manage multiple projects of varying scopes in parallel.
• Experience working as part of or leading cross-functional teams with members from marketing, sales, clinical, regulatory, medical affairs, quality, manufacturing, etc.
• Experience with medical-device design-control processes and creating and maintaining design-control documentation.

Pay

$30–40 per hour

Schedule

40 hours per week, 1st shift