Sr. Design Quality Engineer- Shockwave Medical

Johnson & Johnson

Santa Clara, California, United States of America
Base: $91,000.00 - $147,200.00; bonus/equity: long...
Embedded software and hardware design verification
Iso 13485 and iso 14971 compliance
Risk management and fmea documentation
This role focuses on delivering safe and effective medical device designs in line with Shockwave Medical policies and regulatory guidelines

Job Summary

  • This role focuses on delivering safe and effective medical device designs in line with Shockwave Medical policies and regulatory guidelines.
  • The position requires ensuring design control compliance across hardware, embedded software, and equipment while supporting sustaining engineering improvements.
  • Employees are eligible for a comprehensive benefits package including retirement plans, long-term incentives, and various paid time off options.

Matching Summary

This role focuses on delivering safe and effective medical device designs in line with Shockwave Medical policies and regulatory guidelines.

Salary

Base: $91,000.00 - $147,200.00; Bonus/Equity: Long-term incentive program available; Benefits: Retirement plan, 401(k), vacation, sick time, parental leave

Skills & Requirements

Must-have

  • Embedded Software and Hardware Design Verification
  • ISO 13485 and ISO 14971 compliance
  • Risk Management and FMEA documentation
  • Class III medical device experience
  • Analog and Digital Circuit Design

Nice-to-have

  • Statistical software Minitab application
  • Supplier audit and quality activities
  • Cross-functional team leadership
  • Root cause analysis expertise
  • Fast-paced environment adaptability

Key Requirements

  • Bachelor's degree in software or electrical engineering
  • 5+ years hands-on experience with Embedded Software/Hardware
  • Experience with Class III medical devices
  • Working knowledge of IEC 62304 and 21 CFR Part 820

Work Rights

Not specified

Tailored Resume

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