Senior Design Quality Engineer - Medical Devices (Embedded)

jj; Santa Clara (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Annual performance bonus

Job summary

Johnson & Johnson is hiring for a Sr. Design Quality Engineer – Shockwave Medical to join our Santa Clara, CA team. You will lead hardware and embedded software V&V, ensure regulatory compliance, and drive design quality across the product lifecycle.

The role requires OSS/DO-standards knowledge, risk management, and cross-functional collaboration to deliver safe, effective cardiovascular devices with our Shockwave Medical portfolio.

Qualifications

• Bachelor’s degree in software or electrical engineering; 5+ years embedded software/hardware design and development.
• Experience with Design Verification and Validation testing in the medical device industry.
• Working knowledge of ISO 13485, ISO 14971, IEC 62304/60601, 21 CFR Part 820, EU MDR and MDSAP.

Responsibilities

• Ensure designs meet customer requirements and regulatory guidelines.
• Develop, review, and execute Embedded Software and Hardware System V&V plans, protocols and reports.
• Lead risk analysis activities (FMEA) and manage risk documentation.
• Audit DHFs to ensure compliance with design control procedures.
• Support manufacturing with design-related issues and supplier quality.
• Participate in audits (FDA, Notified Bodies) and quality system improvements.
• Drive CAPA and NCR closure and root cause analysis.
• Collaborate with cross-functional teams to implement process improvements.

Skills

Embedded Software

Hardware Design

Design Verification & Validation

Regulatory Compliance

Risk Management

Statistical Analysis

Cross-functional Collaboration

Documentation & CAPA

Quality System

Education

Bachelor’s in Software/Electrical Engineering

MS in Medical Device Engineering

Tools

Minitab

Git/Version Control

PCB Layout Tools

Job description

Johnson & Johnson is hiring for a Sr. Design Quality Engineer – Shockwave Medical to join our Santa Clara, CA team. You will lead hardware and embedded software V&V, ensure regulatory compliance, and drive design quality across the product lifecycle.

The role requires OSS/DO-standards knowledge, risk management, and cross-functional collaboration to deliver safe, effective cardiovascular devices with our Shockwave Medical portfolio.