Senior R&D Engineer

Location: Salt Lake City, UT • Duration: 5+ months • Hours: 40/week • Pay rate: $40–55/hr • 1st shift • Contract on W2 (US citizens or Green Card holders only)

About the Role

Our client, a medical device company specializing in vascular access devices, is seeking a Senior R&D Engineer to join a team focused on sustaining engineering activities for the VAD portfolio optimization program. This fixed-term position requires working knowledge of Quality Management Systems (ISO 13485), design history files, and risk management (ISO 14971).

Responsibilities

• Lead or support design and development activities for existing products.
• Perform gap assessments and remediation to support 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 and 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 specifying 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 to drive technical success and on-time completion.
• 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 all local, state, federal, and BD safety regulations.

Leadership & Project Management

• Demonstrate strong accountability for successful completion of designated tasks.
• Provide design control leadership to cross-functional teams comprising QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing.
• Proactively develop, maintain, and share technical knowledge in specialized area(s), staying up-to-date on current trends and best practices.

Requirements

• BS degree in engineering (Mechanical or Biomedical) is required; Master’s degree preferred.
• Minimum of 4–6 years of engineering experience.
• Medical device design and development experience related to high-volume manufacturing is strongly preferred.

Skills & Experience

• Demonstrated ability to utilize statistical tools, computer analysis, and engineering fundamentals to support sound engineering judgment.
• Experience with SolidWorks, Minitab, and FEA (Abaqus/Fluent).
• Project leadership and management experience.
• Strong design control experience.
• Experience 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 under 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 plastic injection molding, metal stamping, and automated assembly techniques (solvent bonding, adhesive bonding, ultrasonic welding, interference-fitting).
• Experience with manufacturing process validation, including strategy development, First Article Inspection, Factory Acceptance Testing, and IQ/OQ/PQs.
• Knowledge of disciplined product development processes and regulatory/quality requirements such as 21 CFR 820.30.

Pay

$40–55/hour

Schedule

40 hours/week, 1st shift