Product Engineer III (Medical Devices)

Location: Plano, Texas, United States

Company

Global manufacturer of specialty medical products for interventional radiology, vascular surgery, interventional cardiology, and oncology.

What you will do

• Develop engineering studies and performance data for new product development and competitor analysis.
• Partner with systems and mechanical design engineers to define verifiable product requirements.
• Develop and validate test methods using ASTM, ASME, ISO, FDA, and other industry standards.
• Create design verification plans, protocols, and reports; conduct preclinical verification and design iteration assessments.
• Support root-cause and failure analysis, statistical analysis, risk mitigation, and technical responses for regulatory submissions.
• Execute testing, document results and deviations, and collaborate with clinical engineering, marketing, and cross-functional R&D teams.

Requirements

• BS degree or higher in biomedical, mechanical, electrical, biological, or physical science.
• At least 4 years of medical device industry experience.
• Strong knowledge of medical device industry standards, regulations, and design controls under FDA and MDD/MDR requirements.
• Experience with medical device testing, test method validation, gauge R&R, and measurement system analysis.
• Understanding of manufacturing processes, engineering statistics, statistical analysis software, and fixture design for inspection and testing.
• Availability to travel 5–10% and communicate technical information promptly across teams.

Culture & Benefits

• Work within a mission-driven organization focused on improving patient outcomes through image-guided medical procedures.
• Collaborate with systems, mechanical design, clinical engineering, marketing, quality, and R&D functions.
• May supervise test-lab activities and support laboratory calibration and safety.
• May provide guidance to R&D and cross-functional team members.