R&D Engineer (Required EUMDR AND packaging experience0 - Urgent Need
MillenniumSoft Inc · Salt Lake City, UT · 6 days ago
Engineering$20–$30/hrContract
Location: Salt Lake City, UT • 12-month contract on W2 • 40 hours/week • Pay rate: $20–30/hr • First shift • 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 terms of quality, manufacturing, supply continuity, and cost improvement. 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
- 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 and then into specific product, packaging, and process specifications.
- Engineer robust and manufacturable products through strong understanding and application of engineering fundamentals.
- Develop and execute test methods that 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 client quality policies, procedures, and practices as well as all local, state, federal, and client safety regulations, policies, and procedures.
Requirements
- BS degree in engineering (Packaging, Mechanical, or Biomedical Engineering preferred).
- 1–3 years of packaging engineering experience specifically for medical devices.
- Hands-on experience with ISO 11607-1, EU MDR compliance, EU MDR gap assessment, or EU MDR remediation—all within sterile medical-device packaging.
- Medical-device validations for sterile packages and design-control knowledge.
- Demonstrated ability to utilize statistical tools and computer analysis.