Johnson & Johnson
Principal R&D Engineer (Extrusion) - Shockwave Medical
Johnson & Johnson, Santa Clara, California, us, 95053
Overview
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 Position
Principal R&D Engineer (Extrusion Technology) – Shockwave Medical
– join our team located in Santa Clara, CA. 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. Responsibilities
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 drawings; maintain documentation per quality system requirements (e.g., 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 testing methods in simulated environments; develop new product designs based on defined user needs Collaborate with clinical and scientific advisors and Key Opinion Leaders to translate clinical needs into design solutions Analyze, evaluate, source, and coordinate procurement of new materials to support prototyping and pilot operations; maintain supplier relationships to ensure high-quality components and services Participate as SME or core team member on product development teams from concept through commercialization Ensure proper documentation (component and assembly drawings) consistent with the company quality system Support intellectual property efforts through invention disclosures and patent applications Support company goals, policies, Quality Systems and FDA regulations Develop and optimize extrusion processes, including processing windows, failure limits, process inputs standardization, and monitoring KPIs Familiarity with ISO 13485 standards and FDA regulations for medical devices Knowledge of biocompatibility and sterilization processes for 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 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 adapt 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 Equity and Inclusion
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 inclusive interview process. 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 AskGS to be directed to your accommodation resource. Compensation
The anticipated base pay range for this position is:
$141,000 - $227,700 Benefits and Additional Details
Subject to the terms of applicable plans, employees and/or eligible dependents may participate in Company-sponsored benefit programs including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, retirement and savings plans. Time off benefits include Vacation, Sick time, Holiday pay, Parental Leave, Caregiver Leave, Volunteer Leave, and Military Spouse Time-Off, among others. For additional information, see the CompanyCareers benefits page.
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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 Position
Principal R&D Engineer (Extrusion Technology) – Shockwave Medical
– join our team located in Santa Clara, CA. 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. Responsibilities
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 drawings; maintain documentation per quality system requirements (e.g., 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 testing methods in simulated environments; develop new product designs based on defined user needs Collaborate with clinical and scientific advisors and Key Opinion Leaders to translate clinical needs into design solutions Analyze, evaluate, source, and coordinate procurement of new materials to support prototyping and pilot operations; maintain supplier relationships to ensure high-quality components and services Participate as SME or core team member on product development teams from concept through commercialization Ensure proper documentation (component and assembly drawings) consistent with the company quality system Support intellectual property efforts through invention disclosures and patent applications Support company goals, policies, Quality Systems and FDA regulations Develop and optimize extrusion processes, including processing windows, failure limits, process inputs standardization, and monitoring KPIs Familiarity with ISO 13485 standards and FDA regulations for medical devices Knowledge of biocompatibility and sterilization processes for 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 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 adapt 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 Equity and Inclusion
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 inclusive interview process. 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 AskGS to be directed to your accommodation resource. Compensation
The anticipated base pay range for this position is:
$141,000 - $227,700 Benefits and Additional Details
Subject to the terms of applicable plans, employees and/or eligible dependents may participate in Company-sponsored benefit programs including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, retirement and savings plans. Time off benefits include Vacation, Sick time, Holiday pay, Parental Leave, Caregiver Leave, Volunteer Leave, and Military Spouse Time-Off, among others. For additional information, see the CompanyCareers benefits page.
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