Packaging Engineer [Must Have Medical Device exp]
About The Position
The Packaging Engineer will provide solid technical skill and engineering support for design and development activities for new and existing products. This role will support current products in terms of quality, manufacturing, supply continuity, and cost improvement. The engineer will participate in executing technical and/or cross-functional project work and contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance. Responsibilities include understanding customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies. The engineer will translate customer needs into engineering requirements into specific product, packaging, and process specifications. They will engineer robust and manufactural products through a strong understanding and application of engineering fundamentals. Additionally, the role involves developing and executing test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis. The engineer will write detailed technical reports based on design verification analysis/testing for design changes and product design activities. Ensuring compliance with BD quality policies, procedures, and practices, as well as all local, state, federal, and BD safety regulations, policies, and procedures is crucial.
Requirements
- EUMDR compliance experience or EUMDR gap assessment or EUMDR remediation in packaging medical devices.
- Medical device validations for sterile packages.
- Medical device Design control knowledge.
- ISO11607-1 knowledge.
- BS degree in engineering (Packaging, Mechanical or Biomedical Engineering preferred).
- 1-3 years of experience on packaging engineering for medical devices.
- Experience with ISO 11607.
- Experience with EUMDR gap analysis.
- Experience with sterile content packaging design validations.
- Demonstrated ability to utilize statistical tools and computer analysis.
Responsibilities
- Provide solid technical skill and engineering support for design and development activities for new and existing products.
- 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 BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
