Senior Design Quality Engineer - Shockwave Medical (Medical Devices)

Location: Santa Clara, California, United States

Salary: $91,000–$147,200 annual base pay, plus eligibility for an annual performance bonus.

Company

Johnson & Johnson MedTech develops innovative, less invasive healthcare solutions, including Shockwave Medical’s Intravascular Lithotripsy portfolio for treating calcified cardiovascular disease.

What you will do

• Ensure new designs and design changes comply with medical device regulations, standards, and internal procedures.
• Develop, review, and perform embedded software and hardware system verification and validation plans, protocols, and reports.
• Manage design risk documentation, including risk analyses, FMEAs, and risk management reports.
• Support design reviews, regulatory submissions, audits, supplier quality activities, and continuous improvement of the Quality Management System.
• Investigate non-conformances, complaints, returned devices, NCRs, and CAPAs, including root cause analysis and corrective actions.
• Partner with design, manufacturing, operations, and contract manufacturers to improve product quality and processes.

Requirements

• Bachelor’s degree in software or electrical engineering with 5+ years of relevant hands-on experience, or a master’s degree with 3+ years of experience.
• Experience with embedded software, hardware design and development, and system design verification and validation in the medical device industry.
• Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP.
• Experience with analog and digital circuit design, schematics, PCB layout, prototypes, automation tests, reliability testing, and embedded systems.
• Experience with Class III medical devices, electromechanical products, complaint investigations, statistical analysis, and cross-functional problem solving.
• Strong written and verbal communication, attention to detail, proficiency in Microsoft Word, Excel, and PowerPoint, and the ability to manage multiple priorities.

Nice to have

• Experience with source version control, issue tracking, power and control electronics, MDRs, and vigilance reporting.
• Experience with Minitab and valid statistical techniques for data analysis.

Culture & Benefits

• Full-time employment within an inclusive healthcare innovation environment.
• Medical, dental, vision, life, disability, business accident, and group legal insurance may be available.
• Eligibility for pension and 401(k) savings plans may be available.
• Vacation, sick time, holiday pay, and work, personal, and family time off are provided according to applicable plans.
• Employees may be required to lift objects weighing up to 25 pounds.