Embedded software and hardware system verification and validation
Design control compliance
Risk management files
Johnson & Johnson is seeking a Sr. Design Quality Engineer for their Shockwave Medical division in Santa Clara, CA. The role focuses on ensuring compliance with medical device regulations and supporting the development and verification of innovative medical devices
Job Summary
The Sr. Design Quality Engineer will represent Quality Design Engineering Assurance for hardware and embedded software design, development, and system verification and validation.
This role supports project teams to ensure new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines.
The position is eligible to participate in the Company’s long-term incentive program and offers various time off benefits including vacation, sick time, and holiday pay.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Sr. Design Quality Engineer for their Shockwave Medical division in Santa Clara, CA. The role focuses on ensuring compliance with medical device regulations and supporting the development and verification of innovative medical devices.
Salary
Base: $91,000.00 - $147,200.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off
Skills & Requirements
Must-have
Embedded Software and Hardware System Verification and Validation
Design Control Compliance
Risk Management Files
Medical Device Regulations and Standards
Quality Management System
Nice-to-have
Cross-functional team leadership
Fast-paced environment adaptability
Continuous improvement mindset
Root cause analysis proficiency
Key Requirements
Bachelor's in software/electrical engineering with 5+ years of experience
MS with 3+ years of experience
Working knowledge of medical device regulations and standards
Experience with Analog and Digital Circuit Design
Experience with design and development of embedded systems
Class III medical device experience
Experience with complaint investigations, including MDRs and Vigilance Reporting is preferred