Sr. Design Quality Engineer - Shockwave Medical

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 91,000 - 147,000; Full time

Job summary

Johnson & Johnson is hiring a Sr. Design Quality Engineer – Shockwave Medical in Santa Clara, CA. You will join a team developing next­gen IVL therapy devices, ensuring safe, compliant designs across hardware and embedded software, and leading cross‑functional risk and quality activities.

The role emphasizes Design Verification/Validation planning, process improvements, and regulatory alignment with ISO13485, ISO14971, IEC62304, IEC60601, and related standards.

Qualifications

• Bachelor’s or MS in software/electrical engineering with experience in embedded systems.
• Experience with design verification/validation for medical devices.
• Familiarity with ISO13485, ISO14971, IEC62304, IEC60601 and FDA/Notified Bodies.

Responsibilities

• Ensure design projects comply with medical device regulations and procedures (Design Reviews).
• Develop/Review/Perform embedded software and hardware system V&V plans, protocols and reports.
• Lead cross-functional teams in risk analysis, CAPA, and non-conformance investigations.

Skills

Embedded software

Hardware design

Risk analysis

Minitab

Cross-functional teamwork

Education

Bachelor’s in software/electrical engineering

MS in software/electrical engineering

Tools

MS Word

MS Excel

PowerPoint

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, weare 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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: Johnson & Johnson is hiring for a Sr. Design Quality 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 Sr. Design Quality Engineer (Embedded Software and Hardware System Verification & Validation) works closely and partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures. This position willrepresent Quality Design Engineering Assurance for hardware and embedded software design, development, design system verification and validation and support sustaining engineering to drive improvements with respect to hardware, software, and equipment. This includes supporting project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design and Manufacturing Engineering to improve processes where possible. Provides Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO13485, ISO14971, 21 CFR Part820, MDD93/42/EEC, EU MDR, MDSAP, IEC62304, IEC62366, and IEC60601.

Essential Job Functions Ensures new Design projects and Design Change activities are performed in compliance with medical device regulations, standards, and internal procedures. Participates in Design reviews to document and ensure that the design meets the intended customer requirements. Develops/Reviews/Performs Embedded Software and Hardware System Design Verification and Validation Test Plan, Test Protocols, and Reports. Is a Subject Matter Expert on application of relevant standards, usage of statistical techniques for new Design and Development Projects.Responsible for Risk Management files documents such as Risk Management Plan, Risk Analysis, FailureMode andEffects Analysis (FMEA), Risk Management Reports. Develops device Quality and System V&V Plans to ensure that the elements of the Quality Management System is appropriately described and managed. Provides Software level of concern and classification of Software modules. Audits DHFs toensure compliance with the Design Control procedure. Assists in qualifying molds, fixtures, tooling, and equipment. Perform/support process validations, identify, drive, and implement process improvements. Supportsongoing Regulatorysubmissionactivities and product approvalprocesses. Identifies testing and analysis required to ensure conformance to product specifications. Supports hardware scalability and continuous improvement projects Initiates, reviews, and approves Document Change Orders (DCO.). Provides support for Manufacturing and Operations. Works with contract manufacturers to maintain product quality and resolve any non-conformances that arise. Performs or assists in root cause analysis of product non-conformances found in manufacturing. Evaluates/investigates and documents investigation results for returned devices from clinical studies and commercial complaints. Reviews, investigates, dispositions, and drives to completion Non-conforming Reports (NCR) and CorrectiveandPreventive Actions (CAPA.). Analyzes and reviews data for key Quality metrics to identify any significant trends. Drives Standard Gap Assessment activities. Participates in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.) Participates in the implementation and continuous improvement of the Quality Management System. Provides technical support to the Quality inspection group. Recommends QC sampling plans based on desired confidence and reliability limits. Participates in Supplier Quality activities including material non-conformances and Supplier audits.

J&J Credo: Understands andapplies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. Other duties as assigned.

Requirements Bachelor’s in software/electrical engineering with 5+ years of hands‑on experience with Embedded Software, Hardware Design and Development. System of System Design Verification and Validation Testing in the Medical Device industry or an MS with 3+ years of hands‑on experience with Embedded Software, Hardware Design and Development, System of System Design Verification and Validation Testing in the Medical Device industry. Working knowledge of applicable medical device regulations andstandardsuch as ISO13485, ISO14971, IEC62304, IEC62366, IEC60601, 21 CFR Part820, MDD93/42/EEC, EU MDR, and MDSAP required. Experience with Analog and Digital Circuit Design, schematic layouts, PCB. Layout/ design, prototype development, automation tests, server component validation, stress, and reliability tests. Experience with design and development of embedded systems, Source version control, Issue Tracking, power, and control electronics for use in medical devices and programming experience is highly desired. Responsible for design component and assembly documentation for new products being developed ClassIII medical device experience and electromechanical device product. Ability to perform multiple tasks concurrently with accuracy. Ability to understand regulatory implications of Design Changes. Experience and involvement with complaint investigations, including MDRs and Vigilance Reporting is preferred. Ability to lead cross‑functional teams in problem solving and risk analysis activities. Experience with statistical software such as Minitab and the application of valid statistical techniques for data analysis. 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 lift objects up to 25lbs. Must be able to communicate effectively with all levels of the organization in both verbal and written formats Proficiency in MS Word, Excel and Power Point required High attention to detail and accuracy is required Employee may be required to lift objects up to 25lbs. An internal pre‑identified candidate for consideration has been identified. However, all applications will be considered.

Additional Information 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. Theannual 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 hoursper calendar year Sick time -up to 40 hoursper calendar year; for employees who reside in the State of Washington – up to 56 hoursper calendar year Holiday pay, including Floating Holidays – up to 13 daysper calendar year Work, Personal and Family Time - up to 40 hoursper 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 Section503 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 anaccommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills: Preferred Skills: Analytical Reasoning, Coaching, Customer Centricity, DataSavvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

The anticipated base pay range for this position is : $91,000.00 - $147,200.00

Additional Description for Pay Transparency: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 breakthroughsof tomorrow, and profoundly impacthealth for humanity.Learnmore at https://www.jnj.com/. DoNotSell or ShareMyPersonalInformationLimittheUseofMyPersonalInformation