Sr. Design Quality Engineer- Shockwave Medical

Johnson & Johnson

Santa Clara, California, United States of America
Base: $91,000.00 - $147,200.00; bonus/equity: not ...
Embedded software and hardware system verification
Design control compliance
Risk management files
This position will represent Quality Design Engineering Assurance for hardware and embedded software design, development, design system verification and validation and support sustaining engineering to drive improvements with respect to hardware, software, and equipment

Job Summary

  • This position will represent Quality Design Engineering Assurance for hardware and embedded software design, development, design system verification and validation and support sustaining engineering to drive improvements with respect to hardware, software, and equipment.
  • Provides Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366, and IEC 60601.
  • The anticipated base pay range for this position is : $91,000.00 - $147,200.00

Matching Summary

This position will represent Quality Design Engineering Assurance for hardware and embedded software design, development, design system verification and validation and support sustaining engineering to drive improvements with respect to hardware, software, and equipment.

Salary

Base: $91,000.00 - $147,200.00; Bonus/Equity: Not specified; Benefits: Eligible for Company’s consolidated retirement plan (pension) and savings plan (401(k)), long-term incentive program, 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
  • Design Control Compliance
  • Risk Management Files
  • Medical Device Regulations and Standards
  • Process Validation and Improvement

Nice-to-have

  • Cross-functional Team Leadership
  • Fast-paced Environment Management
  • Data Analysis and Trend Identification
  • Supplier Quality Activities

Key Requirements

  • Bachelor's in software/electrical engineering with 5+ years experience
  • MS with 3+ years experience
  • Class III medical device experience
  • Experience with Analog and Digital Circuit Design
  • Experience with design and development of embedded systems

Work Rights

Not specified

Tailored Resume

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