"Alerted.org

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:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a **Principal R&D Enginee** **r (Extrusion)** **– Shockwave Medica** l to join our team located in **Santa Clara, CA.**

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 (Extrusion Technology) serves as a subject matter expert (SME) in extrusion technology and will focus on developing and optimizing extrusion processes and tooling for multi- and single-lumen tubing used in medical devices. Under minimal supervision, the Principal R&D Engineer will be responsible for leading process and equipment design, driving product innovation from concept to commercialization, and supporting cross-functional teams across all business units.

Essential Job Functions

+ Lead technical development of extrusion processes, tooling and equipment for new products

+ Collaborate with suppliers and vendors for materials, tooling, and process specifications

+ Create and maintain accurate documentation of tool drawings, design concepts and concepts, maintain documentation per quality system requirements (e.g., drawings, protocols, reports)

+ Design, prototype, and test new product concepts; develop manufacturing methods

+ Drive equipment procurement, installation, and validation (IQ/OQ/PQ)

+ Prototype and develop proof of concept designs, mechanical test 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 maintain relationships with suppliers to ensure the delivery of superior components and services

+ Participate as SME or core team member on product development team that manage projects from concept through commercialization

+ Responsible for ensuring proper documentation (component and assembly drawings) consistent with company’s quality system

+ Enhance the intellectual property position of the company via invention disclosures and patent applications

+ Support company goals and objectives, policies and procedures, Quality Systems and FDA regulations

+ Demonstrated expertise in developing and optimizing extrusion processes for medical devices, including the establishment of processing windows and failure limits, standardizing process inputs through product bracketing, and visualizing outputs to determine key performance indicators for effective monitoring

+ Familiarity with ISO 13485 standards and FDA regulations for medical devices

+ Knowledge of biocompatibility and sterilization processes, associated to extruded components

+ May supervise and mentor R&D Technicians as needed

+ Other duties as assigned

Requirements

+ Bachelor’s Degree in Mechanical Engineering or Polymer Science or other relevant engineering 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 tubing extrusion

+ Knowledge of medical-grade polymer extrusion, including tooling, die design and screw/barrel configurations

+ Strong understanding of engineering materials, component selection, and design for reliability and manufacturability

+ Expertise in developing and optimizing extrusion processes, including process window establishment, troubleshooting, and failure analysis

+ Experience with extrusion validation processes (IQ/OQ/PQ)

+ Strong understanding of biocompatibility, sterilization, and regulatory standards (FDA, ISO 13485)

+ Skilled in calibration, SPC, DOE, and risk assessments (PFMEA)

+ Excellent analytical, problem-solving, and critical thinking abilities

+ Strong project management, communication, and interpersonal 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

+ Proficiency in SOLIDWORKS is a strong plus

+ Employee may be required to lift objects up to 25lbs

_Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._

_Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via_ _https://www.jnj.com/contact-us/careers_ _or contact AskGS to be directed to your accommodation resource._

The anticipated base pay range for this position is :

$141,000 - $227,700

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits