Staff NPI Engineer - Johnson and Johnson MedTech, Circulatory Restoration

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 129,000 - 208,000; Full time

Benefits offered by this job

Long-term incentive

Competitive benefits

Job summary

Johnson & Johnson is hiring a Staff NPI Engineer in Santa Clara, CA to drive process development for cardiovascular and peripheral devices. You will partner with R&D, Operations, Regulatory, and Quality to move designs from development into production while upholding quality standards.

The role requires 8+ years in engineering (or 5+ with an advanced degree), medical device exposure, and expertise in DFMA, validation (IQ-OQ-PQ), and SolidWorks.

Qualifications

• Engineering background with medical device industry experience preferred.
• Familiarity with QSRs/FDA/ISO MDR regulatory frameworks.
• Strong problem solving and statistical skills.

Responsibilities

• Collaborate with R&D, QA, and Production to design and validate processes.
• Develop tissue/plastic catheter-related manufacturing steps and fixtures.
• Lead DFMA and design reviews for new and existing products.
• Document protocols, test methods, and validation activities.

Skills

Lean Six Sigma

DOE & Gage R&R

SolidWorks

ERP/MES systems

IQ-OQ-PQ validation

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Master’s degree (recommended)

Tools

SolidWorks

Oracle ERP/MES

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 Staff NPI Engineer 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/. Cardiovascular Solutions from Johnson & Johnson Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary and peripheral artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more information on circulatory restoration, visit our website.

Position Overview The Staff NPI Engineer will utilize technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Staff NPI Engineer will serve as a subject matter expert for the process development team, provide oversight to pilot manufacturing/testing, and guide products as they transition from development into full production. This position will participate in multiple cross-functional development teams, focusing on design for manufacturability, process optimization, and sustaining activities. The Staff NPI Engineer will develop, validate, and implement various processes by working closely with R&D, Operations, Regulatory, and Quality teams to support the company’s manufacturing operations and product launch timelines. This role is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle—from design through production.

Essential Job Functions

• Collaborate with R&D, QA, and Production departments to design, develop, test, document, and implement processes, tooling, and fixtures.
• Develop, validate, and maintain test methods.
• Develop new catheter manufacturing processes based on design intent and DFM principles.
• Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies used in manufacturing processes.
• Performs testing, analyzes results and provides recommendations for design selection.
• Analyze, evaluate, source, and coordinate procurement of new materials to support prototyping pilot operations, and design verification and validation activities.
• Develop protocols/reports and perform product in-vitro, in‑vivo as well as verification and validation testing.
• Participates in technical design reviews to ensure all design inputs and user needs are met.
• Collect data and analyze process performance and capabilities for both new and existing products.
• Perform tolerance analysis for components, manufacturing materials, packaging, and supplies used for in‑house processing.
• Lead efforts to develop and maintain Process Failure Modes and Effects Analyses (pFMEAs).
• Prepare user requirements, technical specifications, and design documentation.
• Identify process requirements, support operations management, and implement necessary equipment and fixtures needed for process development and manufacturing efforts.
• Support product development teams in executing projects from concept to commercialization.
• Contribute to base business and continuous improvement initiatives.
• Support pilot manufacturing and serve as a subject matter expert on design‑related inquiries, including regulatory submissions.
• Ensure proper documentation and compliance with the company’s quality policy, system, and objectives.
• Maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI’s, LHR’s), and other Quality System requirements.
• Evaluate and improve existing engineering processes.
• Lead or participate in problem‑solving initiatives using the DMAIC methodology.
• Lead or support process/product improvement projects in collaboration with R&D engineers and technicians.
• Assist Procurement and R&D in supplier selection and technical development
• Recommend and implement new technologies to enhance system performance and reliability.
• Conduct productivity and costing analyses (e.g., time studies, direct labor/materials costs assessments), proposing scalable solutions.
• Identify and implement cost reduction strategies for existing products.
• Support product line transfers and associated qualification/validation efforts.
• Manage supplier relationships to ensure delivery of high‑quality components and services.
• Enhance the company’s intellectual property portfolio through invention disclosures and patent applications.
• Supports company goals, policies, procedures, qualitySystems, and FDA regulations.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in Mechanical or Biomedical Engineering with 8+ year of engineering experience, or a Master’s degree with 5+ years of engineering experience.
• Engineering experience in the medical device industry is strongly preferred.
• Knowledge of and compliance with applicable Quality System regulations (QSRs, FDA, ISO, MDD, MDR, etc).
• Understanding of Lean and Six Sigma principles.
• Experience with medical device validation (IQ‑OQ‑PQ).
• Basic understanding of statistical methods (e.g., Cpk, Hypothesis Testing, DOE’s, Gage R&R) is a plus.
• Proficiency in SolidWorks for drawing creation and maintenance.
• Experience with ERP and MES (Oracle preferred)
• Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
• Experience in early‑stage catheter‑based cardiovascular devices project is a strong plus.
• Effective communication skills across all levels of the organization.
• Proficiency in Microsoft Office software (Excel, Word, PowerPoint).
• Ability to work in a fast‑paced environment and manage multiple priorities.
• Ability to work independently and collaboratively, with adaptability to changing requirements.
• Must be able to sit for prolonged periods (more than 2 consecutive hours in an 8‑hour day).
• Must be able to lift objects weighing up to 25lbs or more.

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.

Required Skills: Preferred Skills: AI Judgement Integration, Bioinformatics, Biological Engineering, Biostatistics, Coaching, Critical Thinking, Design of Experiments (DOE), Healthcare Trends, Industry Analysis, Innovation, Medicines and Device Development and Regulation, Product Development, Relationship Building, Research and Development, Researching, SAP Product Lifecycle Management, Standard Scientific Processes and Procedures, Technologically Savvy

The anticipated base pay range for this Bay Area position is: $129,000.00 - $208,150.00

Additional Description for Pay Transparency: 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 Colorado –48 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 Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time‑Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

Do Not Sell or Share My Personal Information

Limit the Use of My Personal Information