R&D Engineer (Required EUMDR AND packaging experience0 - Urgent Need

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

Level of Experience: Senior Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

The most important experience that the candidates needs to have for this position is:

• EUMDR compliance experience or EUMDR gap assessment or EUMDR remediation. All these in packaging medical devices.
• Medical device validations for sterile packages
• Medical device Design control knowledge
• ISO11607-1

Position : R&D Engineer

Location : Salt Lake City, UT

Duration : 12 Months

Total Hours/week : 40.00

pay rate-$20-30/hr

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level of Experience: Senior Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

The most important experience that the candidates needs to have for this position is:

• EUMDR compliance experience or EUMDR gap assessment or EUMDR remediation. All these in packaging medical devices.
• Medical device validations for sterile packages
• Medical device Design control knowledge
• ISO11607-1

Job Description

• 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 client quality policies, procedures and practices as well as with all local, state, federal and client safety regulations, policies and procedures.
• 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.