Senior Quality Engineer

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 Med Tech, 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

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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Employer:

Shockwave Medical, Inc.

Job Title:

Senior Quality Engineer

Job Code: A011.10369

Job Location:

Santa Clara, CA

Job Type: Full-Time

Rate of Pay: $145,205 - $155,369

Job Duties:

Provide Design Quality Assurance to efficiently deliver safe and effective medical device designs for manufacturing. Provide Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other applicable regulations, Work closely and partner with internal departments to ensure designs are aligned with company policies and procedures.

Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound initiation of new processes with adequate and appropriate process controls. Support project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines, and work closely with Design and Manufacturing Engineering to improve processes where possible. Participate in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications.

Provide guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices. Develop and maintain calibration requirements for tools and equipment in the R&D, Manufacturing, and Quality areas. Analyze nonconformance reports and returned products, and recommend corrective action. Write detailed and accurate technical documents to be submitted for regulatory review.

Requirements:
Employer will accept a Master's degree in Mechanical Engineering, Biomedical Engineering or related field and 3 years of experience in the job offered or in a Senior Quality Engineer-related occupation.

This job posting is anticipated to close on 7/17/2026.

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  or contact AskGS to be directed to your accommodation resource.

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…