Principal R&D Engineer (Balloon Tech) - Shockwave

Role Summary

Principal R&D Engineer (Balloon Technology) – Shockwave Medical in Santa Clara, CA. Lead technical development for IVL balloon devices and new balloon technologies across peripheral, coronary, and heart valve applications, driving projects from concept through commercialization.

Responsibilities

• Provide technical leadership for projects including managing technology development teams
• Design and develop products in compliance with Design Control requirements and regulatory standards
• Translate finished device requirements to the balloon component level in collaboration with Adv. R&D and PDP teams
• Survey emerging balloon and polymer technologies and explore novel applications to support strategic goals
• Identify and apply new balloon/polymer technologies to improve current and next-generation products
• Develop long-term strategy with Technologies Development Team for new designs, materials, and processing methods
• Prototype and develop proof-of-concept designs, disease models, and testing methods; design products based on user needs
• Collaborate with clinical advisors and Key Opinion Leaders to translate clinical needs into design solutions
• Source and coordinate procurement of new materials for prototyping and pilot operations; maintain supplier relationships
• Participate as SME or core team member on product development teams from concept to commercialization
• Ensure proper documentation (component and assembly drawings) in line with quality systems
• Plan activities consistent with quality policy and objectives
• Develop protocols/reports and perform in-vitro, in-vivo, verification, and validation testing
• Enhance the company IP position via invention disclosures and patent applications
• Maintain knowledge of competitive technologies and medical/technical developments related to products
• Support company goals, quality systems, and FDA regulatory compliance
• Other duties as assigned

Qualifications

• Bachelor‚Äôs Degree in Mechanical Polymer Science or another relevant engineering/technical field with 10 years of medical device experience, or Master‚Äôs Degree with 8 years of experience
• 3+ years of polymer product development experience 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/manufacturability
• Proven track record in technology development and/or early-stage R&D; ability to plan and execute toward evolving goals
• Proven project leadership skills
• Effective communication across management levels
• Ability to work independently and adapt to changing requirements; fast-paced environment with multiple priorities
• Previous experience managing cross-functional teams preferred
• Proficiency in SOLIDWORKS; Design of Experiments is a strong plus
• May be required to lift up to 25 lbs

Skills

• Technical leadership
• Balloon technology and polymer science
• Device design and design control compliance
• Prototyping, testing (in-vitro/in-vivo), and validation
• Material selection and supplier management
• IP development and patent awareness
• Cross-functional collaboration with clinical and advisory teams

Education

• Bachelor‚Äôs or Master‚Äôs in Mechanical, Polymer Science, or related engineering field