Not specified (assumed on-site based on job location)
Embedded software and hardware design verification
Iso 13485 and iso 14971 regulatory compliance
Risk management and fmea documentation
Johnson & Johnson is seeking a Sr. Design Quality Engineer for its Shockwave Medical division in Santa Clara, California. The role focuses on ensuring compliance with medical device regulations, collaborating with cross-functional teams, and driving product quality improvements
Job Summary
This role focuses on delivering safe and effective medical device designs for Shockwave Medical's Intravascular Lithotripsy portfolio.
The engineer will ensure compliance with global regulations including ISO 13485, IEC 62304, and EU MDR while managing risk files.
Employees are eligible for comprehensive benefits including a 401(k), long-term incentives, and up to 480 hours of parental leave.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Sr. Design Quality Engineer for its Shockwave Medical division in Santa Clara, California. The role focuses on ensuring compliance with medical device regulations, collaborating with cross-functional teams, and driving product quality improvements.
Salary
Base: $91,000.00 - $147,200.00; Bonus/Equity: Long-term incentive program available; Benefits: 401(k), pension, vacation, sick time, parental leave
Skills & Requirements
Must-have
Embedded Software and Hardware Design Verification
ISO 13485 and ISO 14971 Regulatory Compliance
Risk Management and FMEA Documentation
Class III Medical Device Experience
Analog and Digital Circuit Design Knowledge
Nice-to-have
Statistical Analysis with Minitab
Supplier Quality Auditing Experience
Cross-functional Team Leadership
Root Cause Analysis in Manufacturing
Fast-paced Environment Adaptability
Key Requirements
Bachelor's in software/electrical engineering with 5+ years experience