Senior Design Quality Engineer, MedTech Embedded Systems

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

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.