Senior Medical Device Software QA Engineer - Hybrid

Analog Devices; Wilmington (MA); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Analog Devices, Inc. in Wilmington, MA, is seeking a hands-on Senior Design Quality Engineer to own QA activities across the product lifecycle from concept through commercialization.

You will ensure design controls, risk management, verification and validation, and regulatory compliance for medical device software while maintaining strong ownership and alignment with QA leadership. You will lead the QA owner role for assigned projects, drive design quality improvements, and collaborate with

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 7+ years of medical device Quality Engineering experience.
• Experience with IEC 62304 and FDA guidance for software in medical devices.

Responsibilities

• Lead QA activities across the product lifecycle from concept to commercialization.
• Maintain and review design control deliverables and risk documentation.
• Manage the eQMS and quality records including risk management.
• Authorize, review, and drive verification and validation activities and reports.
• Collaborate with cross-functional teams to ensure regulatory compliance.

Skills

Quality Engineering

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Analog Devices, Inc. in Wilmington, MA, is seeking a hands-on Senior Design Quality Engineer to own QA activities across the product lifecycle from concept through commercialization.

You will ensure design controls, risk management, verification and validation, and regulatory compliance for medical device software while maintaining strong ownership and alignment with QA leadership. You will lead the QA owner role for assigned projects, drive design quality improvements, and collaborate with