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The most important experience that the candidates needs to have for this position is: 1) EUMDR compliance experience or EUMDR gap assessment or EUMDR remediation. All these in packaging medical devices. 2) Medical device validations for sterile packages 3) Medical device Design control knowledge 4) ISO11607-1
Job Responsibility:
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
Requirements:
BS degree in engineering is required (Packaging, Mechanical or Biomedical Engineering preferred)
1-3 years of experience on packaging engineering for medical devices required, ISO 11607, EUMDR gap analysis, sterile content packaging design validations
Demonstrated ability to utilize statistical tools and computer analysis
EUMDR compliance experience or EUMDR gap assessment or EUMDR remediation. All these in packaging medical devices