Manufacturing Engineer II Shockwave

Santa Clara County, CA - USA

Yearly Salary: $ 73000 - 117300

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara California United States of America

Job Description:

Description - External

Johnson & Johnson is hiring for aManufacturing Engineer II - Shockwave Medicalto join our team located inSanta 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 Manufacturing Engineer II is responsible for providing engineering support to Production. Also responsible for designing developing testing and implementing processes tooling and fixtures for commercial addition the Manufacturing 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.

Qualifications - External

Bachelors degree in engineering.
3-5 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 DOEs Gage R&R) a plus.
Able to create and maintain Drawings in SolidWorks.
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.
Experience with MES and ERP (Oracle) preferred
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.

Additional Information:

The anticipated base pay for this position is $73000.00 to $117300 annually.
The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.
Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
- Holiday pay including Floating Holidays up to 13 days per calendar year
- Work Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
NOTE:This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.
This job posting is anticipated to close on March 11 2025. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.
Johnson & Johnson is an Affirmative Action and 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 or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit.

The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara California United States of America

Job Description:

Description - External

Johnson & Johnson is hiring for aManufacturing Engineer II - Shockwave Medicalto join our team located inSanta Clara CA.

Position Overview

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.

Qualifications - External

Bachelors degree in engineering.
3-5 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 DOEs Gage R&R) a plus.
Able to create and maintain Drawings in SolidWorks.
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.
Experience with MES and ERP (Oracle) preferred
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.

Additional Information:

The anticipated base pay for this position is $73000.00 to $117300 annually.
The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.
Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
- Holiday pay including Floating Holidays up to 13 days per calendar year
- Work Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
NOTE:This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.
This job posting is anticipated to close on March 11 2025. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.
Johnson & Johnson is an Affirmative Action and 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 or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit.

The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

Key Skills

Lean Manufacturing
Six Sigma
CNC Programming
Lean
Machining
Tooling
CAD
CNC
Assembly Experience
SolidWorks
Kaizen
Manufacturing

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About Company

Johnson & Johnson

About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more

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