Manufacturing Engineer II - Shockwave

Biopharma Asia; Santa Clara (CA); On-site; USD 73,000 - 117,000; Full time

Benefits offered by this job

Annual performance bonus

Medical, dental, vision insurance

Retirement plan (401(k))

Vacation up to 120 hours per year

Job summary

Johnson & Johnson in Santa Clara, CA is hiring a Manufacturing Engineer II - Shockwave Medical to join our team. This role provides engineering support to Production and develops processes, tooling, and fixtures for commercial products.

You will drive process improvements, participate in NPI transfers, and ensure quality systems compliance. The ideal candidate has a Bachelor's in engineering and 3–5 years in a medical device setting, with experience in Lean Six Sigma and MES/ERP systems.

Qualifications

• Bachelor’s degree in engineering.
• 3–5 years in a medical device environment.
• Knowledge of QSRs, FDA, ISO, MDD, MDR requirements.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• SolidWorks drawings experience.
• Ability to work in a fast-paced environment and manage priorities.
• Experience with MES and ERP (Oracle) preferred.

Responsibilities

• Actively collaborate with Production to resolve product/process/equipment problems.
• Identify and participate in process/product, tooling, equipment, fixtures and cost reduction projects.
• Coordinate testing and analysis with stats using Minitab or Excel.
• Support new product introductions, including scale-up and transfer to alternate sites.
• Develop and maintain MPIs, FMEAs, and DMR documents.
• Create, maintain and transfer BOMs and LHRs into Item Structures and definitions.
• Support resolution of quality events (NCR, CAPA, audits).
• Create and release label files for product labels.
• Execute process validation protocols and reports.

Skills

Lean Six Sigma

Statistical methods

Team orientation

Problem solving

Fast-paced environment

Education

Bachelor’s degree in engineering

Tools

SolidWorks

MES

ERP (Oracle)

Minitab/Excel data analysis

Job description

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

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 a Manufacturing 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 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 product. In 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 (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.

Qualifications - External

• Bachelor’s 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, DOE’s, 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 $73,000.00 to $117,300 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 corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s 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 Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• 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. https://www.careers.jnj.com/employee-benefits

The 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 https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Aff... (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 www.careers.jnj.com .

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: