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: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.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 year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
- Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
- This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
- For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Required Skills: Preferred Skills: 
