NPI Engineer II Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 NPI Engineer II Shockwave Medical 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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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 Engineer II will use technical skills in the development of innovative products to treat peripheral coronary and heart valve diseases. The NPI Engineer II will focus on process development for the engineering team providing oversight to pilot manufacturing/testing and see products transition from development into full production. This position will participate on multiple cross-functional development teams that focus on process optimization sustaining and design NPI Engineer II will develop validate and implement various processes by working closely with research/development operations regulatory and quality addition the NPI Engineer II will sustain activities on the production line such as raw material process and equipment issues.

Essential Job Functions

• Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.

• Actively identify and participate in process/product tooling equipment fixtures and cost reduction improvement projects.

• Coordinate and/or perform functional and destructive testing to support Engineering Reports. Document the results and provide a statistical analysis using Minitab or excel.

• Participate as an extended team member for new product introduction including scaling up stabilizing and transfer to alternate sites.

• Participate in development and maintenance of process FMEAs Manufacturing Process Instructions (MPIs) and Device Master Record (DMR) documents.

• Create maintain and transfer paper Bill of Materials (BOMs) and Lot History Records (LHRs) into Item Structures Work Definitions and electronic LHRs.

• Support efforts to resolve Quality related events (NCR CAPA Audit Finding) and maintain other Quality System Requirements.

• Create and release label files used for printing product labels.

• Create and execute process validation protocols and reports.

• 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

• Bachelors degree in Mechanical or Biomedical Engineering

• Min 3 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 DOEs 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 or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Bioinformatics Biological Engineering Biological Sciences Biostatistics Data Reporting Data Savvy Design of Experiments (DOE) Detail-Oriented Execution Focus Feasibility Studies Preclinical Research Problem Solving Process Oriented Prototyping Report Writing Research and Development Researching SAP Product Lifecycle Management Technologically Savvy

The anticipated base pay range for this position is :

$87000.00 - $140300.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys 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: - Experience:

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