Johnson & Johnson MedTech
Staff NPI Engineer - Shockwave Medical
Johnson & Johnson MedTech, Santa Clara, California, us, 95053
Staff NPI Engineer – Shockwave Medical
Location: Santa Clara, California, United States
Overview Johnson & Johnson MedTech is hiring a Staff NPI Engineer to join our team in Santa Clara, CA. The role focuses on the development and commercialization of intravascular lithotripsy (IVL) technology, supporting the next generation of smarter, less invasive cardiovascular treatments.
Responsibilities
Collaborate with R&D, QA, Production, and Regulatory teams to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
Develop, validate, and maintain process and test methods throughout the product lifecycle.
Design and improve catheter manufacturing processes based on design intent and DFM principles.
Provide technical documentation such as drawings, specifications, and reports for manufacturing processes.
Conduct testing, analyze results, and recommend design improvements.
Source, evaluate, and procure materials for prototyping and validation activities.
Participate in technical design reviews and ensure design inputs and user needs are met.
Analyze process performance and conduct tolerance analyses for manufacturing components.
Lead and maintain Process Failure Mode Effects Analyses (pFMEA).
Support pilot manufacturing, serve as SME on design‑related inquiries, and assist with regulatory submissions.
Apply DMAIC methodology to problem‑solving initiatives.
Implement cost‑reduction and productivity improvement strategies.
Maintain compliance with quality policies, system, and FDA regulations.
Qualifications
Bachelor’s degree in Mechanical or Biomedical Engineering with 8+ years of experience, or Master’s degree with 5+ years of experience.
Strong preference for experience in the medical device industry.
Knowledge of Quality System regulations (QSR, FDA, ISO, MDD, MDR).
Understanding of Lean and Six Sigma principles.
Experience with device validation (IQ‑OQ‑PQ) and statistical methods (Cpk, DOE, Gage R&R).
Proficiency in SolidWorks and experience with ERP/MES systems (Oracle preferred).
Familiarity with disposable peripheral and coronary device design, material selection, and testing.
Effective communication and collaboration skills.
Capacity to work independently, manage multiple priorities, and lift up to 25 lbs.
Skills
Process development and optimization.
Technical documentation and design control.
Supplier selection and procurement.
Statistical process control.
Project management and cross‑functional teamwork.
Knowledge of catheter‑based cardiovascular devices.
Compensation & Benefits Base salary range: $125,000 – $201,250 annually. Eligible for performance bonuses and standard company‑sponsored benefits.
Equal Opportunity Employment 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, or protected veteran status. The company actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you require an accommodation, please contact the Employee Health Support Center.
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Overview Johnson & Johnson MedTech is hiring a Staff NPI Engineer to join our team in Santa Clara, CA. The role focuses on the development and commercialization of intravascular lithotripsy (IVL) technology, supporting the next generation of smarter, less invasive cardiovascular treatments.
Responsibilities
Collaborate with R&D, QA, Production, and Regulatory teams to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
Develop, validate, and maintain process and test methods throughout the product lifecycle.
Design and improve catheter manufacturing processes based on design intent and DFM principles.
Provide technical documentation such as drawings, specifications, and reports for manufacturing processes.
Conduct testing, analyze results, and recommend design improvements.
Source, evaluate, and procure materials for prototyping and validation activities.
Participate in technical design reviews and ensure design inputs and user needs are met.
Analyze process performance and conduct tolerance analyses for manufacturing components.
Lead and maintain Process Failure Mode Effects Analyses (pFMEA).
Support pilot manufacturing, serve as SME on design‑related inquiries, and assist with regulatory submissions.
Apply DMAIC methodology to problem‑solving initiatives.
Implement cost‑reduction and productivity improvement strategies.
Maintain compliance with quality policies, system, and FDA regulations.
Qualifications
Bachelor’s degree in Mechanical or Biomedical Engineering with 8+ years of experience, or Master’s degree with 5+ years of experience.
Strong preference for experience in the medical device industry.
Knowledge of Quality System regulations (QSR, FDA, ISO, MDD, MDR).
Understanding of Lean and Six Sigma principles.
Experience with device validation (IQ‑OQ‑PQ) and statistical methods (Cpk, DOE, Gage R&R).
Proficiency in SolidWorks and experience with ERP/MES systems (Oracle preferred).
Familiarity with disposable peripheral and coronary device design, material selection, and testing.
Effective communication and collaboration skills.
Capacity to work independently, manage multiple priorities, and lift up to 25 lbs.
Skills
Process development and optimization.
Technical documentation and design control.
Supplier selection and procurement.
Statistical process control.
Project management and cross‑functional teamwork.
Knowledge of catheter‑based cardiovascular devices.
Compensation & Benefits Base salary range: $125,000 – $201,250 annually. Eligible for performance bonuses and standard company‑sponsored benefits.
Equal Opportunity Employment 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, or protected veteran status. The company actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you require an accommodation, please contact the Employee Health Support Center.
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