Senior R&D Engineer

4 hours ago


Salt Lake, Utah, United States MILLENNIUMSOFT Full time
Job Title: Senior R&D Engineer

We are seeking a highly skilled Senior R&D Engineer to join our team in Salt Lake City, UT. As a Senior R&D Engineer, you will be responsible for leading design and development activities for existing products, including product design, gap assessment and remediation, and participating in executing technical and/or cross-functional project work.

Key Responsibilities:
  • Lead or support design and development activities for existing products.
  • Gap assessment and remediation supporting product regional registration.
  • 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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