Senior Medical Device Design Quality Engineer

Analog Devices

MA, United States
$110,385 to $151,808; discretionary performance-ba...
Design control and risk management
Quality management system procedures
Medical device file maintenance
This role plays a critical part in ensuring the quality, safety, and regulatory compliance of our medical product portfolio

Job Summary

  • This role plays a critical part in ensuring the quality, safety, and regulatory compliance of our medical product portfolio.
  • Provide Design Quality Engineering support throughout the product development lifecycle ensure compliance with regulations and internal Quality Management System procedures.
  • This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time , and other benefits.

Matching Summary

This role plays a critical part in ensuring the quality, safety, and regulatory compliance of our medical product portfolio.

Salary

$110,385 to $151,808; Discretionary performance-based bonus; Medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time

Skills & Requirements

Must-have

  • Design control and risk management
  • Quality Management System procedures
  • Medical Device File maintenance
  • Root cause analysis and CAPA
  • Cross-functional team collaboration

Nice-to-have

  • Advancements in digitized factories
  • Bridging physical and digital worlds
  • Fostering continuous improvement
  • Partnering effectively across teams

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Minimum 5 years of work experience
  • Medical Device industry experience preferred
  • Knowledge of 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR

Work Rights

Export licensing review may be required for non-US citizens

Tailored Resume

Cover Letter