Senior R&D Engineer

Job Description Summary

The Senior R&D Engineer will be part of a team focused on sustaining engineering activities to support the VAD portfolio optimization program. The successful candidate will be responsible for product design, gap assessment and remediation, and leadership in project management.

Minimum Qualifications

• 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.
• Experience to include:
• 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.