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:

Johnson & Johnson is hiring for a Sr. Manufacturing Engineer, Tech Development – Shockwave 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 Senior Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures for throughout the product lifecycle, from design to production. This is inclusive of bringing new innovative solutions to ensure business goals are met. The Senior 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.

• Support and work with Quality to address and resolve non-conformances.

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

• 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.

• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology. Main objective is to improve process through innovation and efficient application and development of technologies. This is includes NPD, NPI and Operation projects.

• Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians).

• Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity

• Assist Procurement and R&D departments with supplier selection and technical development.

• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products).

• 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 Engineering. Preferably, Mechanical, Electrical or similar degree

• Minimum of five (5) years of experience in a medical device environment or, 3 years of experience with a Master’s Degree.

• Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements)

• Experience with implementing Lean and Lean Sigma concepts.

• Experience with Validation of Medical Devices (IQ-OQ-PQ).

• Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R)

• 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 25lbs.

Additional Information:

• The anticipated base pay for this position is $105,400-$142,600 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

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 and 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 email the Employee Health Support Center ( ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

Additional Description for Pay Transparency:

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.