Sr. Design Quality Engineer- Shockwave Medical

Johnson & Johnson UK

Santa Clara, California, United States
$91,000.00 - $147,200.00; not specified; not speci...
Embedded software and hardware system verification
Design control compliance
Risk management files
The Sr. Design Quality Engineer will represent Quality Design Engineering Assurance for hardware and embedded software design, development, and validation, supporting sustaining engineering to drive improvements

Job Summary

  • The Sr. Design Quality Engineer will represent Quality Design Engineering Assurance for hardware and embedded software design, development, and validation, supporting sustaining engineering to drive improvements.
  • This role involves ensuring new design projects and design change activities comply with medical device regulations, standards, and internal procedures, including participation in design reviews and development of V&V plans.
  • Employees are eligible for a comprehensive benefits package including retirement plans, long-term incentive programs, and various paid time off benefits such as vacation, sick time, and parental leave.

Matching Summary

The Sr. Design Quality Engineer will represent Quality Design Engineering Assurance for hardware and embedded software design, development, and validation, supporting sustaining engineering to drive improvements.

Salary

$91,000.00 - $147,200.00; Not specified; Not specified

Skills & Requirements

Must-have

  • Embedded Software and Hardware System Verification
  • Design Control Compliance
  • Risk Management Files
  • Medical Device Regulations and Standards
  • Process Validation

Nice-to-have

  • Customer Centricity
  • Technologically Savvy
  • Analytical Reasoning
  • Data Savvy
  • Process Improvements

Key Requirements

  • Bachelor's in software/electrical engineering with 5+ years of experience
  • MS with 3+ years of experience
  • Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP
  • 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

Work Rights

Not specified

Tailored Resume

Cover Letter