Sr. NPI Engineer - Shockwave Medical

Quest Oracle Community; Santa Clara, Northern (CA, KY); Hybrid; USD 106,000 - 170,000; Full time

Job summary

Johnson & Johnson seeks a Senior NPI Engineer for the Shockwave Medical program in Santa Clara, CA. You will design, develop, test and implement processes, tooling and fixtures across the product lifecycle, collaborating with R&D, QA, RA and Production to support new product introductions and manufacturing readiness.

The role requires medical device experience, Lean Six Sigma expertise, and strong documentation practices to ensure FDA/ISO compliance and successful launches.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• Min 5 years of experience in a medical device environment.
• Knowledge of FDA, ISO, MDR and other Quality System requirements.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Ability to create and maintain Drawings in SolidWorks; ERP/MES experience (Oracle preferred).

Responsibilities

• Design, develop, test, document and implement processes, tooling, and fixtures.
• Support quality to address non-conformances.
• Collect data and analyze process performance for new and existing products.
• Identify process requirements and support equipment/fixturing development for manufacturing.
• Develop and maintain design control documentation and manufacturing procedures.
• Lead DMAIC-based process and product improvement projects.
• Apply Lean manufacturing principles to reduce waste and increase productivity.
• Collaborate with Procurement and R&D on supplier selection and process development.

Skills

DMAIC

Lean Six Sigma

Statistics

SolidWorks

ERP/MES (Oracle)

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP/MES (Oracle)

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 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 Senior NPI Engineer - Shockwave Medica l 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 NPI Senior Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures for throughout the product lifecycle, from design to production. The NPI Senior Engineer will work closely with production, quality, and R&D teams to support the company's manufacturing operations and product launch timelines.

Essential Job Functions

• Work collaboratively with R&D, QA, RA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Support and work with Quality to address and resolve non-conformances.
• Collect data and analyze process performance and capabilities for new processes development company products, including new products and products already in production.
• Identify process requirements, advise and support operations management, design and development implement equipment and fixturing needed for process development and manufacturing efforts.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI's, LHR's), and company's Design Control requirements and consistent with FDA, ISO, MDR and other Quality System requirements.

• Prototype and develop designs, processes, and test methods in support of new product designs scaling for commercialization
• Develop protocols/reports and perform process verification and validation testing
• Represents Operations as a primary point of contact on manufacturing-related project activities, including internal and external requests and perform process-related tasks to support pilot manufacturing
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company's product.

• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians).
• Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity
• Assist Procurement and R&D departments with supplier selection and process development.
• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new and existing products, identify and implement cost reduction plans for existing products).

• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Requirements

• Bachelor's degree in Mechanical or Biomedical Engineering
• Min 5 years of experience in a medical device environment.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE's, Gage R&R) a plus.
• Able to create and maintain Drawings in SolidWorks.
• 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 with all levels of management and organizations
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to lift objects up to 25lbs or more.
• Employee will be required to work in an air-conditioned Class 8 Cleanroom.

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.

Preferred Skills

Analytical Reasoning, Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Coaching, Data Savvy, Detail-Oriented, Feasibility Studies, Inventory Management, Preclinical Research, Project Schedule, Prototyping, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy

The anticipated base pay range for this position is :

$106,000.00 - $170,200.00

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