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 Quality Engineer (Medical Devices) — Multi-Portfolio Startup
Location: US-based, Wilmington, MA (hybrid will be considered)
Function: Quality
Reports to: Head of Quality Management
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 SummaryHands-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 ResponsibilitiesThe 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.
- 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 time
Shift 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.
Skills Required
- Bachelor's degree in Engineering, Life Sciences, or related technical field.
- 7+ years experience in Quality Engineering, Design Quality Engineering, or product development quality roles within the medical device industry.
- Strong experience supporting design controls, risk management, and verification & validation activities.
- Experience with electronic Quality Management Systems (eQMS) and management of design inputs, risk documentation, and quality records.
- Authoring and supporting test method validation activities, including Gauge R&R and Attribute Agreement Analysis.
- Authoring and driving risk management activities (Risk Management Plans, Hazard Analyses, FMEAs, Risk Management Reports).
- Support for medical device software lifecycle and usability engineering processes (IEC 62304 and IEC 62366-1).
- Experience working in a startup or fast-paced product development environment.
Analog Devices Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Analog Devices and has not been reviewed or approved by Analog Devices.
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Retirement Support — The 401(k) program is described as a standout feature, with company contribution up to 8% of base salary and immediate vesting. This structure strengthens long-term value even when cash compensation perceptions vary.
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Healthcare Strength — Health coverage is positioned as comprehensive, including medical, dental, and vision options along with disability and life insurance. Day-one eligibility and multiple plan choices add to perceived robustness.
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Leave & Time Off Breadth — Paid time off appears broad, with vacation ranging from roughly 17–25 days and increasing up to five weeks with tenure, alongside sick time and paid holidays. Parental leave and related time-off provisions further expand coverage.
Analog Devices Insights
What We Do
Analog Devices, Inc. (NASDAQ: ADI) operates at the center of the modern digital economy, converting real-world phenomena into actionable insight with its comprehensive suite of analog and mixed signal, power management, radio frequency (RF), and digital and sensor technologies. ADI serves 125,000 customers worldwide with more than 75,000 products in the industrial, communications, automotive, and consumer markets. ADI is headquartered in Wilmington, MA.
