Role: Product Development Engineer - Medical Devices

Location: Temecula, CA

Job Description:

The most important experience that the candidates need to have for this position is:
1) FFS (form fill seal) materials and package development for sterile medical devices
2) Experience in and knowledge of ISO 11607-1
2) Medical device validations for sterile packages
3) Medical device Design Control and Quality System knowledge and experience

• Provide solid technical skill and engineering support for design and development activities for new and existing products, focused on device and kit packaging
• Support current products in terms of quality, manufacturing, supply continuity and cost improvement.
• Participate in executing technical and/or cross-functional project work. Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance.
• Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.
• Translate customer needs into engineering requirements into specific product, packaging and process specifications.
• Engineer robust and manufactural products through strong understanding and application of engineering fundamentals.
• Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis. Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.
• Ensure compliance with quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures.
• BS degree in engineering is required (Packaging, Mechanical, or Biomedical Engineering preferred).
• 1-3 years of experience in packaging engineering and materials for medical devices required, ISO 11607, sterile content packaging design validations.
• Demonstrated ability to utilize statistical tools and computer analysis.
• Packaging sustainability experience is a plus.