Balloon Technology R&D Lead Engineer (IVL)

Biopharma Careers; Santa Clara (CA); On-site; USD 141,000 - 228,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, vision

Retirement plan (401k)

Vacation time up to 120 hours

Job summary

Johnson & Johnson in Santa Clara, CA, is hiring a Principal R&D Engineer (Balloon Technology) to lead the development of IVL balloon devices and new balloon technologies for cardiovascular applications.

The role requires strong polymer/device experience, cross-functional leadership, and the ability to translate clinical needs into robust design solutions; active collaboration with clinicians and regulatory teams is essential.

Qualifications

• Bachelor’s Degree in Mechanical Polymer Science or related field; 10 years in medical devices or Master’s + 8 years.
• 3+ years in polymer product development including balloon blow molding.
• Knowledge of disposable peripheral and coronary device design, material selection, testing.
• Strong understanding of engineering materials, components, reliability and manufacturability.
• Proven track record in technology development or early-stage R&D; planning and execution.
• Proven project leadership skills and cross-functional teamwork.
• Effective communication across management levels.
• Ability to operate independently in a fast-paced environment with multiple priorities.
• Experience managing cross-functional teams is preferred.
• Proficiency in SOLIDWORKS; DOE is a plus.
• Physically capable of lifting up to 25 lbs.

Responsibilities

• Provide technical leadership for technology development projects.
• Design and develop products under Design Control and regulatory requirements.
• Translate device requirements to balloon component level with teams.
• Survey balloon/polymer tech; explore novel applications to meet goals.
• Apply new balloon technologies to improve products.
• Develop long-term strategy for new designs and materials.
• Prototype and develop proof-of-concept designs and tests.
• Collaborate with clinical/scientific advisors and KOLs to translate needs into design.
• Coordinate procurement of new materials and manage supplier relationships.
• Participate as SME on product development teams through commercialization.
• Maintain documentation per quality system.
• Align activities with quality policy and objectives.
• Develop protocols/reports and perform in-vitro/in-vivo tests.
• Support IP activities through disclosures and patent apps.
• Keep current on competitive, medical and biomedical developments.
• Support company policies, FDA regulations, and quality systems.

Skills

Polymer product development

Balloon blow molding

Disposable peripheral devices

Coronary device design

Engineering materials

Design for reliability/manufacturabil

Technology development

Project leadership

Effective communication

Independent working

Fast-paced/work prioritization

Cross-functional leadership (preferred

SOLIDWORKS

Physical ability

Education

Bachelor’s Degree in Mechanical Polymer Science

Tools

SOLIDWORKS

Job description

Johnson & Johnson in Santa Clara, CA, is hiring a Principal R&D Engineer (Balloon Technology) to lead the development of IVL balloon devices and new balloon technologies for cardiovascular applications.

The role requires strong polymer/device experience, cross-functional leadership, and the ability to translate clinical needs into robust design solutions; active collaboration with clinicians and regulatory teams is essential.