Design Quality Engineer Ii, Lifecycle

Johnson & Johnson MedTech

Danvers, Massachusetts, United States of America
Base: $92,000.00 - $148,350.00; bonus/equity: not ...
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Design assurance engineering activities
Risk management and analysis
Design verification and validation
** Johnson & Johnson MedTech is seeking a Design Quality Engineer II to support lifecycle processes for medical devices, particularly single-use heart pumps. The role involves risk management, design verification, and ensuring compliance with regulatory standards, while promoting continuous improvement and innovation. **

Job Summary

  • This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products!
  • You will be responsible for supporting and leading Design Assurance engineering activities in support of Abiomed’s Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting.
  • The anticipated base pay range for this position is : $92,000.00 - $148,350.00

Matching Summary

Match Score: 75

** Johnson & Johnson MedTech is seeking a Design Quality Engineer II to support lifecycle processes for medical devices, particularly single-use heart pumps. The role involves risk management, design verification, and ensuring compliance with regulatory standards, while promoting continuous improvement and innovation. **

Salary

Base: $92,000.00 - $148,350.00; Bonus/Equity: Not specified; Benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year

Skills & Requirements

Must-have

  • Design Assurance engineering activities
  • Risk management and analysis
  • Design verification and validation
  • Regulatory compliance (FDA QSRs, ISO 13485)
  • Manufacturing process support

Nice-to-have

  • Voice of quality
  • Independent decision maker
  • Mentor newer QE's
  • Challenging current thinking

Key Requirements

  • Bachelor degree in Engineering or Sciences
  • Minimum of 3 years of quality experience
  • Medical device industry experience
  • Cardiovascular devices experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter