Lead Medical Device R&D Engineer – Spine Innovations

Boston Scientific; San Jose (CA); On-site; USD 117,000 - 222,000; Full time

Job summary

Boston Scientific in San Jose, CA is seeking a Principal R&D Engineer – P5 to lead development of energy-based and non-energy spinal products from concept through testing and commercialization. You will manage cross-functional teams, conduct bench-top and pre-clinical studies, coordinate verifications, and ensure compliance with IEC 60601, FDA, ISO, and other standards.

This on-site role demands a strong track record in medical devices, hands-on design, and the ability to translate clinical

Qualifications

• Bachelor's, master's or doctoral degree in mechanical, industrial, electrical or biomedical engineering.
• Minimum of 10 years' experience in engineering product design.
• Minimum of 5 years' experience in the medical device industry.
• Demonstrated track record of developing, launching and commercializing products.
• Experience developing energy-based medical devices (RF, ultrasound, microwave or cryo).
• Hands-on experimental engineering with electromechanical medical devices.
• Ability to lead multi-disciplinary teams and manage multiple projects.
• Understanding of IEC 60601, ISO, FDA, and ANSI/AAMI standards.

Responsibilities

• Lead and contribute as a team member in design, development, and manufacturing of spinal products (energy-based and non-energy-based).
• Coordinate verification and validation activities, including protocols.
• Plan and execute bench-top, pre-clinical and cadaver studies for regulatory and R&D needs.
• Provide technical leadership and cross-functional collaboration across sales, marketing, clinical and regulatory teams.

Skills

Leadership

Project management

Cross-functional teamwork

Medical device development

Concept to commercialization

Education

Engineering degree (Bachelors/Masters/PhD)

Tools

SolidWorks

CAD modeling

GD&T

Prototyping

Regulatory standards knowledge

Job description

Boston Scientific in San Jose, CA is seeking a Principal R&D Engineer – P5 to lead development of energy-based and non-energy spinal products from concept through testing and commercialization. You will manage cross-functional teams, conduct bench-top and pre-clinical studies, coordinate verifications, and ensure compliance with IEC 60601, FDA, ISO, and other standards.

This on-site role demands a strong track record in medical devices, hands-on design, and the ability to translate clinical