Senior R&D Engineer

1 day ago


Salt Lake, Utah, United States MILLENNIUMSOFT Full time

Job Title – Senior R&D Engineer



Location – Salt Lake City, UT



Duration – 5+ Months



Total Hours/week

1st Shift



Client: Medical Device Company



Job Category: Engineering



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



No H1B's



Description:



Job Description Summary

We are seeking a highly skilled Senior R&D Engineer to join our team in Salt Lake City, UT. The successful candidate will be responsible for leading design and development activities for existing products, participating in executing technical and/or cross-functional project work, and contributing to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance.

Key Responsibilities:

Lead or support design and development activities for existing products.

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.

Analyze design solutions using engineering first principles and advanced engineering methods such as FEA.

Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis.

Develop design verification traceability matrices and associated requirements analysis.

Collaborate and lead in developing project schedules and drive technical success and on time completion per project schedule.

Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.

Ensure compliance with BD quality policies, procedures, and practices as well as with all local, state, federal and BD safety regulations, policies and procedures.

Requirements:

BS degree in engineering (Mechanical or Biomedical) is required. A Master's degree in engineering is preferred.

Minimum of 4-6 years of engineering experience is required. Medical device design and development experience related to high-volume manufacturing is strongly preferred.

Demonstrated ability to utilize statistical tools, computer analysis and engineering fundamentals to support sound engineering judgment. Solidworks, Minitab, and FEA (Abaqus / Fluent) experience is preferred.

Project leadership and management experience is a preferred.

Strong design control experience.

Experience with developing innovative solutions to complex problems.

Strong understanding of DOE and statistical methods.

Strong understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions.

Experience with clinical studies, human physiology, and simulated product use studies.

Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping and automated assembly techniques, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting.

Experience with manufacturing process validation including strategy development, First Article Inspection, Factory Acceptance Testing, and IQ/OQ/PQ's.

Knowledge of disciplined product development processes, regulatory and quality requirements such as 21CFR820.30


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