NPI Engineer II - Shockwave Medical

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 87,000 - 140,300; Full time

Benefits offered by this job

401(k) plan

Long-term incentive program

Vacation accrual

Job summary

Johnson & Johnson in Santa Clara, CA, is hiring an NPI Engineer II to advance intravascular lithotripsy (IVL) product development and support transition from development to production. You will work with research, operations, regulatory, and quality teams to optimize processes and ensure readiness for manufacturing.

The role emphasizes process development, pilot manufacturing oversight, and sustaining activities on the production line while solving complex technical issues in a fast-paced

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• 3+ years in a medical device environment.
• Knowledge of QSRs, FDA, ISO, MDD/MDR and related regulations.

Responsibilities

• Actively collaborate with Production to provide sustaining support for product/process/issues.
• Participate in process FMEAs, MPIs, and DMR documentation.
• Create, validate, and release label files for product labels.
• Develop and execute process validation protocols and reports.

Skills

Medical device development

Lean Six Sigma

Validation IQ-OQ-PQ

Statistical methods (Cpk, DOE)

Documentation (DMR, MPIs)

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Oracle ERP/MES

Minitab

Excel

Job description

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

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 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 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.

Employee Rights and Diversity

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

• Required Skills: (none listed)

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

Pay & Benefits

The anticipated base pay range for this position is : $87,000.00 - $140,300.00

• 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 period
• 10 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