Principal R&D Engineer (Balloon Tech) - Shockwave

Role Summary

The Principal R&D Engineer (Balloon Technology) will develop innovative balloon-based devices to treat peripheral, coronary, and heart valve diseases. Based in Santa Clara, CA, they will participate on cross-functional teams from concept through commercialization, supporting IVL balloon-related devices and exploring new balloon technologies for future applications.

Responsibilities

• Provide technical leadership for projects including managing technology development teams
• Design and develop product(s) in compliance with Design Control and regulatory requirements
• Translate finished device requirements to the balloon component level in collaboration with Adv. R&D and PDP teams
• Survey emerging balloon and polymer science technologies to support strategic goals
• Identify practical applications of new balloon/polymer technologies to improve current and next-generation products
• Execute long-term strategy with Technologies Development Team for next-generation balloon concepts
• Prototype and develop proof-of-concept designs, disease models, and test methods in simulated environments
• Collaborate with clinical advisors and key opinion leaders to translate clinical needs into design solutions
• Procure materials for prototyping and pilot operations; manage supplier relationships for quality components
• Participate as SME or core team member on product development teams from concept to commercialization
• Ensure proper documentation (e.g., component and assembly drawings) per quality system
• Plan activities aligned with quality policy and objectives
• Develop protocols/reports and perform in-vitro, in-vivo, verification, and validation testing
• Contribute to intellectual property via invention disclosures and patent applications
• Maintain knowledge of competitive technologies and related medical/technical developments
• Support quality systems and FDA regulatory compliance
• Other duties as assigned

Qualifications

• Bachelor’s Degree in Mechanical/Polymer Science or related engineering field with 10 years’ medical device experience, or Master’s Degree with 8 years’ medical device experience
• 3+ years of polymer product development including balloon blow molding
• Knowledge of disposable peripheral and coronary device design, material selection, and testing
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
• Proven track record in technology development and/or early-stage R&D; ability to progress toward defined goals
• Proven project leadership skills
• Effective communication skills across management levels
• Ability to operate independently and adapt to changing requirements
• Ability to work in a fast-paced environment with multiple priorities
• Previous cross-functional team leadership experience preferred
• Proficiency in SOLIDWORKS and Design of Experiments is a plus
• May be required to lift objects up to 25 lbs

Skills

• Technical leadership
• Balloon technology and polymer science knowledge
• Design Control and regulatory compliance
• Prototyping, testing, and validation
• Cross-functional collaboration
• Intellectual property development
• Material science and supplier management

Additional Requirements

• May require lifting up to 25 lbs