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Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Santa Clara, California, United States of AmericaJob Description:
Employer: Shockwave Medical Inc.
Job Title: Quality Engineer II
Job Code: A011.10374
Job Location: Santa Clara, CA
Job Type: Full-Time
Rate of Pay: $105,000 - $115,000 per year
Job Duties: Develop, apply, revise and maintain quality standards for processing materials/products into partially or finished products. Design and implement methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment. Support manufacturing and work cross-functionally to resolve technical problems. Participate in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Process, investigate, and complete customer complaints. Prepare documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans. Assess if components, sub-assemblies, and products meet specification and can initiate, investigate, and resolve non-conformances by working in conjunction with a multidisciplinary team. Participate in developing the risk management documentation including (Hazard assessment, design trace matrix development, DV&V testing, and FMEA). Practice company safety, quality policies and procedures and participate in internal/external audits.
Requirements: Employer will accept a Bachelor's degree in Bioengineering, Biomedical Engineering or related field and 2 years of experience in the job offered or in a Quality Engineer II-related occupation.
Position requires experience in:
1. Medical device industry;
2. Performing failure/ Product Non-conformance investigations;
3. Production line support including non-conformance investigation and product disposition, supporting process changes and process validation activities including IQ, OQ, and PQ;
4. Technical writing skills for investigations, design and process verification and validation protocols and reports;
5. Developing risk management documentation including plans, hazard assessment, design trace matrix development, DV&V testing, and FMEA;
6. Conducting statistical analysis using minitab or equivalent tools for process capability and data normality assessments, analysis of variance, and hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications; and
7. ISO, ASTM, and FDA standards for quality within the medical device industry.
This job posting is anticipated to close on 10/26/2026.
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 https://www.jnj.com/contact-us/careers 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 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:
Skills Required
- Bachelor's degree in Bioengineering, Biomedical Engineering, or a related field
- Two years of experience in the job offered or a Quality Engineer II-related occupation
- Experience in the medical device industry
- Experience performing failure and product non-conformance investigations
- Experience supporting production lines, non-conformance investigations, product disposition, process changes, and IQ/OQ/PQ process validation
- Technical writing experience for investigations, design verification and validation protocols, and reports
- Experience developing risk management documentation, including hazard assessments, design trace matrices, DV&V testing, and FMEA
- Experience conducting statistical analysis using Minitab or equivalent tools, including capability analysis, normality assessments, ANOVA, hypothesis testing, sample sizing, tolerance intervals, DOE, and sampling plans
- Knowledge of ISO, ASTM, and FDA quality standards for the medical device industry
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
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Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
