Principal R&D Engineer (Balloon Tech) - Shockwave
Johnson & Johnson
Full-time
Remote friendly (San Francisco, CA)
United States
$141,000 - $227,700 USD yearly
Clinical Research and Development
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Role Summary
Principal R&D Engineer (Balloon Technology) – Shockwave Medical at Santa Clara, CA. Develop and commercialize IVL balloon-related devices; explore new balloon technologies to address future applications; provide technical leadership across cross-functional teams.
Responsibilities
- Provide technical leadership for projects including managing technology development teams
- Design and develop product(s) in compliance with the company’s 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 technologies in balloons and polymer science; explore novel applications to support company goals
- Identify practical ways to apply new balloon/polymer technologies to improve current and next-generation products
- Execute a long-term strategy with Technologies Development Team for examining new designs, materials, and processing methods
- Prototype and develop proof-of-concept designs, disease models, and test methods; develop new product designs based on user needs
- Collaborate with clinical advisors and KOLs to translate clinical needs into design solutions
- Procure and manage 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 (e.g., drawings) consistent with quality systems
- Plan activities aligned with quality policy and objectives
- Develop protocols/reports and perform in-vitro and in-vivo as well as verification and validation testing
- Enhance IP position via invention disclosures and patent applications
- Maintain knowledge of competitive technologies and related medical/technical developments
- Support company goals, Quality Systems, and FDA regulations
- Other duties as assigned
Qualifications
- Bachelor’s Degree in Mechanical Polymer Science or relevant engineering/technical field with 10 years’ medical device experience, or Master’s Degree with 8 years’ experience
- 3+ years 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; ability to plan and execute toward evolving goals
- Proven project leadership skills
- Effective communication across management levels
- Ability to operate independently and adapt to changing requirements
- Ability to work in a fast-paced environment with multiple priorities
- Experience managing cross-functional teams preferred
- Proficiency in SOLIDWORKS and Design of Experiments preferred
- Lift objects up to 25 lbs as needed
Skills
- Technical leadership
- Design Control compliance
- Balloon technology and polymer science
- Prototype development and testing (in-vitro/in-vivo)
- Material sourcing and supplier management
- Project management and cross-functional collaboration
- Communication with clinical advisors and KOLs
Education
- Bachelor’s or Master’s in Mechanical Polymer Science or related engineering/technical field
Additional Requirements
- Ability to lift up to 25 lbs