R&D Engineer (Must Have EUMDR compliance experience in packaging medical devices)

Location: Salt Lake City, UT | Duration: 12 months | Hours: 40/week | Pay rate: $20–30/hr (1st shift) | Employment type: Contract on W2 (US citizens or green-card holders only)

About the role

Provide solid technical skill and engineering support for design and development activities for new and existing medical-device products. Support current products in quality, manufacturing, supply continuity, and cost improvement. Participate in technical and cross-functional project work, contribute to innovation, and help translate customer needs into engineering requirements and product specifications.

Responsibilities

• Execute design and development activities for new and existing medical devices.
• Support quality, manufacturing, supply continuity, and cost-improvement initiatives for current products.
• Participate in technical and cross-functional project execution.
• Generate novel concepts for new products and enhancements to current product performance.
• Understand customer needs through literature review, interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated-use studies.
• Translate customer needs into engineering requirements and specific product, packaging, and process specifications.
• Engineer robust, manufacturable products using strong engineering fundamentals.
• Develop and execute test methods specifying 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 client quality policies, procedures, and practices, as well as all local, state, federal, and client safety regulations.

Requirements

• BS degree in engineering (Packaging, Mechanical, or Biomedical Engineering preferred).
• 1–3 years of packaging engineering experience for medical devices.
• Experience with ISO 11607-1, EU MDR compliance, EU MDR gap assessment, or EU MDR remediation—specifically in sterile medical-device packaging.
• Medical-device validations for sterile packages and design-control knowledge.
• Demonstrated ability to utilize statistical tools and computer analysis.