What you'd actually do

Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.

Collect data and analyze process performance and capabilities for company products, including new products and products already in production.

Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company processes.

Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI’s, LHR’s), and other Quality System requirements.

Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.

Skills

Required

Bachelor’s degree in Mechanical or Biomedical Engineering
Minimum of eight (8) years of experience in a medical device environment or equivalent experience in other industries (pharmaceutical or automotive) that use the same principles of operation and similar regulations, or 6 years of experience with a Master’s Degree.
Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing
Experience applying statistics and using statistical software, running Capability Studies (Cpk’s), and planning and analyzing DOE’s.
Demonstrated proficiency in written and verbal communication, including creating and delivering presentations.
Ability to use special software such as: Solidworks, Minitab or closely related.
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.

Nice to have

Employee may be required to occasionally lift objects up to 25 lbs.

What the JD emphasized

Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.

Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing

Experience applying statistics and using statistical software, running Capability Studies (Cpk’s), and planning and analyzing DOE’s.

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

**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 Staff Manufacturing Engineer, Shockwave Medical to join our team located in Santa Clara, CA.

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 Staff Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures for throughout the product lifecycle, from design to production. The Staff Manufacturing Engineer will work closely with production, quality, and R&D teams to support the company’s manufacturing operations and product launch timelines.

Essential Job Functions

Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
Perform tolerance analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company processes.
Prepare user requirements, technical specifications, and design specifications.
Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process development and manufacturing efforts.
Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI’s, LHR’s), and other Quality System requirements.
Evaluate existing engineering processes and implements process improvements.
Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
Lead and/or actively participates in process/product improvement projects (in cooperation with production, R&D engineers and technicians).
Assist Procurement and R&D departments with supplier selection and technical development.
Recommend new technologies to improve system performance and reliability. Performs productivity and costing analyses (e.g., calculate direct labor, time studies& materials costs for new and existing products), providing solutions that improve efficiency and scalability for years to come.
Identify opportunities and implement cost reduction plans for existing products.
Support the transfer of product lines and the qualification-validation efforts.
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 Mechanical or Biomedical Engineering
Minimum of eight (8) years of experience in a medical device environment or equivalent experience in other industries (pharmaceutical or automotive) that use the same principles of operation and similar regulations, or 6 years of experience with a Master’s Degree.
Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing
Experience applying statistics and using statistical software, running Capability Studies (Cpk’s), and planning and analyzing DOE’s.
Demonstrated proficiency in written and verbal communication, including creating and delivering presentations.
Ability to use special software such as: Solidworks, Minitab or closely related.
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 occasionally lift objects up to 25 lbs.

Additional Information:

The anticipated base pay range for this position $105,000 to 169,050 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)).
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. 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 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.

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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: