R&d Engineer

About the role

Join our dynamic team as an R&D Engineer, where you will play a pivotal role in designing and verifying cutting-edge medical devices. Utilize your expertise in mechanical engineering to create innovative test fixtures and collaborate with suppliers to ensure product quality and manufacturability.

Responsibilities

• Design custom test fixtures and perform mechanical verification testing, including tensile/pull strength, torque, flex life, bend fatigue, seal/leak integrity, and post-sterilization durability testing, in accordance with industry standards and FDA 21 CFR Part 820 requirements.
• Collaborate with tubing suppliers, adhesive manufacturers, and component vendors to establish mechanical tolerances, material specifications, and repeatable assembly processes.
• Develop precision mechanical assemblies using thin wall or standard wall stainless steel tubing and medical-grade adhesives.
• Contribute to the development of rigid instruments, flexible shafts, or deflectable devices for single-use or reusable applications.
• Apply working knowledge of medical device design controls, test method validation, risk management, ISO standards, and design failure mode and effects analysis (dFMEA).

Requirements

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related field.
• 4+ years of hands-on medical device R&D engineering experience, preferably with catheters, endoscopic instruments, or minimally invasive surgical devices.
• Practical knowledge of medical-grade adhesives, including selection, dispensing, curing, and bond testing.
• Understanding of medical device sterilization methods and their effects on polymer degradation, optical clarity, and adhesive joint integrity.

Qualifications

• Experience with integrating miniature imaging components such as micro-CMOS cameras, LED/fiber-optic illumination.
• Knowledge of designing fluid-tight, hermetic, or chemical-resistant seals.
• Familiarity with pull-wire steering or deflection mechanisms.
• Experience with Design of Experiments (DOE) and statistical analysis.
• Medical device product development experience with Class I or Class II devices.
• Knowledge of FDA Quality System Regulation, ISO standards, usability, sterilization, and biocompatibility.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan
• Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Pay

The pay range for this position is $40.00 - $62.50/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.