Analogdevices
Sr. Design Quality Engineer
US, MA, Wilmington · Senior
Sponsorship not specified$96k-$131kDetected 12 days ago
Product ManagementRoboticsMedical Devices
About the role
- 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.
- Work effectively within small, cross-functional teams while managing multiple priorities and assignments.
- 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.
Responsibilities
- 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.
- 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.
Requirements
- Travel up to 10% as required.
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- Required Travel: Yes, 10% of the time
Nice to have
- Experience working in a startup or fast-paced product development environment preferred.
Skills
- About Analog Devices
- 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.
Compensation
- $96k-$131k
Benefits
- Support compliance activities related to medical device software lifecycle processes (IEC 62304) and usability engineering (IEC 62366-1).
- 7+ years of experience in Quality Engineering, Design Quality Engineering, or product development quality roles within the medical device industry.
- 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.
- Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.
Equal opportunity
- Notice of Applicant Rights Under the Law.
- Analog Devices is an equal opportunity employer.
- EEO is the Law: Notice of Applicant Rights Under the Law.
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This listing is sourced directly from Analogdevices's careers page and normalized into a canonical job model.