Principal R&D Engineer (Balloon Tech) - Shockwave

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 141,000 - 227,700; Full time

Benefits offered by this job

Annual performance bonus

Long-term incentive program

Medical, dental, and vision insurance

401(k) and retirement plans

Up to 120 hours of vacation

Job summary

Shockwave Medical in Santa Clara is looking for a Principal R&D Engineer to lead the technical development of balloon devices used in intravascular lithotripsy. This role requires collaboration with cross-functional teams from concept through to commercialization, focusing on innovative balloon and polymer technology.

The successful candidate will have extensive experience in the medical device industry, with a strong emphasis on polymer product development and engineering materials selection. Competitive compensation and comprehensive benefits are offered.

Qualifications

• 10 years of experience in the medical device industry or a Master’s with 8 years.
• 3+ years of polymer product development experience.
• Strong understanding of engineering materials and design for manufacturability.

Responsibilities

• Lead technical development of intravascular lithotripsy balloon devices.
• Manage technology development teams from concept to commercialization.
• Develop new balloon and polymer technologies for future applications.

Skills

Polymer product development

Engineering materials selection

Project leadership

Effective communication

Cross-functional team management

SOLIDWORKS

Education

Bachelor’s Degree in Mechanical/Polymer Science

Master’s Degree in relevant field

Job description

Position Overview

The Principal R&D Engineer (Balloon Technology) at Shockwave Medical leads technical development of intravascular lithotripsy balloon devices. The role involves managing cross‑functional teams through concept to commercialization and developing new balloon and polymer technologies for future applications.

Essential Job Functions

• Provide technical leadership for projects and manage technology development teams.
• Design and develop products in compliance with company Design Control requirements and applicable regulatory requirements.
• Partner with Advanced R&D and PDP teams to translate finished device requirements to the balloon component level.
• Survey emerging balloon and polymer technologies and explore novel applications to support strategic goals.
• Develop practical applications of new balloon/polymer technologies to improve current and next‑generation products.
• Execute a long‑term strategy with the Technologies Development Team for new designs, materials, and processing methods.
• Prototype and develop proof‑of‑concept designs, disease models, and test methods in a simulated environment; base new product designs on defined user needs.
• Work with clinical and scientific advisors and Key Opinion Leaders to translate clinical needs into design solutions.
• Analyze, evaluate, source, and procure new materials for prototyping and pilot operations; maintain supplier relationships.
• Act as SME or core team member on product development teams managing projects from concept to commercialization.
• Ensure proper documentation (e.g., component and assembly drawings) consistent with the company’s quality system.
• Plan and execute activities consistent with the company’s quality policy and objectives.
• Develop protocols/reports and perform in‑vitro, in‑vivo, verification, and validation testing.
• Enhance intellectual property position via invention disclosures and patent applications.
• Maintain current knowledge of competitive and technical developments related to company products.
• Support company goals, policies, procedures, quality systems, and FDA regulations.
• Other duties as assigned.

Qualifications

• Bachelor’s Degree in Mechanical/Polymer Science or related engineering/technical degree with 10 years’ experience in the medical device industry, or a Master’s Degree with 8 years’ 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 and manufacturability.
• Proven track record in technology development and/or early‑stage R&D; able to plan and execute tasks toward loosely defined research goals.
• Proven successful project leadership skills.
• Effective communication skills with all levels of management and organizations.
• Ability to operate independently and adapt to changing requirements.
• Ability to work in a fast‑paced environment and manage multiple priorities.
• Previous experience managing cross‑functional teams is preferred.
• Proficiency in SOLIDWORKS and Design of Experiments is a strong plus.
• Employee may be required to lift objects up to 25 lbs.

Additional Information

Salary range: $141,000 – $227,700. Eligible for annual performance bonus, long‑term incentive program, and company‑sponsored benefit programs including medical, dental, vision, life insurance, disability, accident, legal insurance, 401(k), and retirement plans. Vacation up to 120 hours per calendar year, sick time up to 40 hours (or 56 hours for Washington state residents), holidays, and paid time off as applicable.

Equal Opportunity Employer

Johnson & Johnson is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status, and the organization will not discriminate on the basis of disability.