Senior Design Software Quality Engineer

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

The responsibilities listed below are representative of the position and are not intended to be an exhaustive list of all duties that may be assigned.

• 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, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.

EEO is the Law: Notice of Applicant Rights Under the Law.

Job Req Type: ExperiencedRequired Travel: Yes, 10% of the timeShift Type: 1st Shift/DaysThe expected wage range for a new hire into this position is $95,600 to $131,450.

• Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.

• This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.

• This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.