Principal R&D Engineer (Balloon Tech) - Shockwave

Role Summary

The Principal R&D Engineer (Balloon Technology) will lead the development of balloon-based devices to treat peripheral, coronary, and heart valve diseases. The role involves participating on cross-functional teams from concept through commercialization, supporting IVL balloon-related devices, and developing new balloon technologies for future applications. Location: Santa Clara, CA.

Responsibilities

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

Qualifications

• Bachelor’s Degree in Mechanical, Polymer Science, or other relevant engineering/technical field with 10 years of medical device experience, or a Master’s Degree with 8 years of medical device experience
• 3+ years of experience in 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 with ability to progress toward defined goals
• Proven project leadership skills
• Effective communication skills across management levels
• Ability to work independently and adapt to changing requirements; able to manage multiple priorities in a fast-paced environment
• Previous experience managing cross-functional teams preferred
• Proficiency in SOLIDWORKS; Design of Experiments is a strong plus
• Ability to lift objects up to 25 lbs

Skills

• Project leadership
• Balloon technology and polymer science
• Prototype development and testing (in-vitro and in-vivo)
• Design for reliability and manufacturability
• Regulatory and quality systems compliance
• Proficiency in SOLIDWORKS; Design of Experiments (DOE)

Education

• Bachelor’s Degree in Mechanical, Polymer Science, or related engineering field; or Master’s Degree with relevant medical device experience

Additional Requirements

• Possible travel as needed; no explicit travel requirements stated
• Physical lifting up to 25 lbs may be required