Senior Design Software Quality Engineer

Analog Devices; Wilmington (MA); On-site; 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

About Analog Devices

Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at www.analog.com and on LinkedIn and X .

Senior Design Software Quality Engineer (Medical Devices) - Multi-Portfolio Startup

Location: US-based, Wilmington, MA (hybrid will be considered)

Function: Quality

Reports to: Head of Quality Management

Company Overview

Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible™. Learn more at www.analog.com and on LinkedIn and Twitter (X) . You will be working within a small, stealth group of talented individuals at ADI focused on next‑generation technologies solving some of the world's toughest problems around human and planetary health.

Position Summary

Hands‑on Sr. Design Quality Engineer serving as the primary QA owner for assigned projects, driving design quality activities across the product lifecycle from concept through commercialization. Responsible for ensuring compliance with design controls, risk management, verification and validation, and applicable regulatory requirements, while maintaining strong ownership and alignment with QA management.

Core Responsibilities

• Execute quality assurance activities throughout product design and development in accordance with applicable regulations, standards, and company procedures.
• Support the development, maintenance, and review of design control deliverables.
• Support implementation and maintenance of the electronic Quality Management System (eQMS), including management of design inputs, risk management documentation, and other quality and product records.
• Author, review, and drive verification and validation activities, including protocols, reports, and closure documentation.
• Author and/or support test method validation activities, including Gauge R&R studies, Attribute Agreement Analysis, and software tool validation.
• Author, review, and drive risk management activities, including Risk Management Plans, Hazard Analyses, FMEAs, and Risk Management Reports.
• Collaborate with cross‑functional teams to ensure design control activities are executed in accordance with company procedures and applicable regulatory requirements.
• Support Quality Management System (QMS) compliance, continuous improvement initiatives, and audit readiness activities.
• Support compliance activities related to medical device software lifecycle processes (IEC 62304) and usability engineering (IEC 62366‑1).
• Work effectively within small, cross‑functional teams while managing multiple priorities and assignments.
• Travel up to 10% as required.

Education, Experience and Background Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 7+ years of experience in Quality Engineering, Design Quality Engineering, or product development quality roles within the medical device industry.
• Hands‑on experience applying IEC 62304 requirements and relevant FDA guidance to the design and development of medical devices containing software
• Strong experience supporting design controls, risk management, and verification & validation activities.
• Experience working in a startup or fast‑paced product development environment preferred.

For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process.

Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marita