Principal R&D Engineer (Balloon Tech) - Shockwave

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

R&D Product Development

Job Sub Function

Biomedical Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Milpitas, California, United States of America, Mountain View, California, United States of America, Palo Alto, California, United States, San Francisco, California, United States of America, San Jose, California, United States of America, South San Francisco, California, United States of America, US356 CA Santa Clara - 5303 Betsy Ross Drive

Job Description

Johnson & Johnson is hiring for a Principal R&D Engineer (Balloon Technology) – Shockwave Medical to join our team located in Santa Clara, CA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Principal R&D Engineer (Balloon Technology) will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Principal R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization. They will support product development efforts in our IVL balloon related devices as well as develop new balloon technologies to address the anticipated needs of future applications.

Essential Job Functions

• 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 consistent with applicable regulatory requirements.
• Partner with the Adv. R&D and PDP teams to translate finished device requirements to the balloon component level
• Survey emerging technologies in the balloons and polymer science space and explore novel applications to support company strategic 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 as well as processing methods for next-generation balloon concepts
• Prototype and develop proof of concept designs, disease models and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs.
• Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design.
• Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation as well as to maintain relationships with suppliers to ensure the delivery of superior components and services.
• Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization.
• Responsible for ensuring proper documentation (e.g., component and assembly drawings) consistent with company’s quality system.
• Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives.
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
• Enhance the intellectual property position of the company via invention disclosures and patent applications.
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
• Other duties as assigned.

Qualifications

• Bachelor’s Degree in Mechanical Polymer Science or other relevant engineering/technical degree and 10 years’ experience in the medical device industry or a Master’s Degree and 8 years’ experience in medical devices.
• 3+ years of experience in polymer product development including experience with 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; capable of planning and executing tasks for progressing towards a loosely defined research goal.
• Proven successful project leadership skills.
• Effective communication skills with all levels of management and organizations.
• Ability to operate independently and adaptability to changing requirements.
• Ability to work in a fast-paced environment, managing 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 25lbs.

Additional Information

• The anticipated salary range for this position is $141,000 - $227,700.
• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
• The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
• Johnson & Johnson is an Affluent 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 will not be discriminated against on the basis of disability.
• For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
• The anticipated base pay range for this position is: $141,000 - $227,700

Additional Description for Pay Transparency

• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.