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NPI Engineer II - Shockwave Medical

Johnson & Johnson MedTech · Santa Clara, CA

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Level
Engineer
Team
Manufacturing
Base pay
$87k–$140k
Degree
Required
Experience asked
3+ years
Industry
Medical devices
Posted
30+ days ago

The role in 30 seconds

An engineer-level manufacturing role at Johnson & Johnson MedTech (medical devices) in Santa Clara, CA. In addition, the NPI Engineer II will sustain activities on the production line such as raw material, process and equipment issues.

They ask for
3+ years · degree required
Tools it names
Lean, Six Sigma, FMEA, MSA / Gage R&R, CAPA, DOE
Base pay
$87k–$140k

Read from the posting. The full description is below.

It asks for 3+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Lifts up to 25 lbs

Pulled from the posting text. If it's not listed here, the posting didn't say.

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About the role

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 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, 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.
Show full 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 NPI Engineer II – 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 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 support. The NPI Engineer II will develop, validate, and implement various processes by working closely with research/development, operations, regulatory, and quality teams. In 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 (BOM’s) and Lot History Records (LHR’s) into Item Structures, Work Definitions and electronic LHR’s.
  • •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

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