Senior R&D Engineer, Medical Device Packaging & Compliance

MillenniumSoft Inc; Salt Lake City (UT); On-site; USD 28,000 - 41,000; Full time

Job summary

MillenniumSoft Inc. in Salt Lake City, UT, seeks a Senior R&D Engineer for a 12-month W2 contract. You will provide engineering support for design and development of medical devices, focusing on packaging, ISO11607-1, and EUMDR alignment.

Responsibilities include design validation, quality/compliance, cross-functional collaboration, and creating robust analyses to improve manufacturability and cost.

Qualifications

• BS degree in engineering (Packaging, Mechanical or Biomedical preferred).
• 1-3 years of packaging engineering for medical devices experience.
• ISO11607, EUMDR gap analysis, sterile content packaging design validations.

Responsibilities

• Provide engineering support for design and development of new and existing products.
• Support quality, manufacturing, supply continuity and cost improvement.
• Participate in cross-functional project work.
• Translate customer needs into engineering requirements for product and packaging specs.
• Develop and execute test methods with measurement equipment and data analysis.
• Ensure compliance with client quality policies and safety regulations.

Skills

EUMDR compliance

EUMDR gap analysis

EUMDR remediation

Sterile packaging validation

Design control knowledge

ISO11607-1

Education

BS in Engineering

Tools

Statistical tools

Data analysis

Job description

MillenniumSoft Inc. in Salt Lake City, UT, seeks a Senior R&D Engineer for a 12-month W2 contract. You will provide engineering support for design and development of medical devices, focusing on packaging, ISO11607-1, and EUMDR alignment.

Responsibilities include design validation, quality/compliance, cross-functional collaboration, and creating robust analyses to improve manufacturability and cost.