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

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

Job summary

MillenniumSoft Inc. in Salt Lake City, UT, seeks a Senior R&D Engineer for a 12-month contract (W2). You will provide solid technical engineering support for design and development of new and existing medical device products, with emphasis on packaging and sterile contents.

Responsibilities include validating packaging, applying design controls, and ensuring ISO11607-1 and EUMDR compliance. Ideal candidates have 1-3 years in medical device packaging engineering and strong statistical analysis

Qualifications

• BS degree in engineering is required; packaging, mechanical or biomedical preferred.
• 1-3 years of experience in packaging engineering for medical devices.
• ISO 11607 and EUMDR gap analysis experience.
• Demonstrated ability to utilize statistical tools and data analysis.

Responsibilities

• 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 manufacturable 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.

Skills

EUMDR compliance experience

EUMDR gap assessment

EUMDR remediation

Medical device validations

Design control knowledge

ISO11607-1

Education

BS degree in Engineering

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.