Senior Medical Device Design Quality Engineer

Analog Devices•Wilmington, MA

About The Position

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, 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) . Senior Medical Device Design Quality Engineer Job Summary We are seeking an experienced and highly motivated Senior Design Quality Engineer to join our dynamic team. This role plays a critical part in ensuring the quality, safety, and regulatory compliance of our medical product portfolio. The ideal candidate will bring deep experience in medical device design quality, strong technical problem‑solving skills, and the ability to partner effectively across engineering, regulatory, and operational teams.

Requirements

A minimum of a bachelor’s degree in engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
Minimum 5 years of work experience in a highly regulated industry is required. Medical Device industry is preferred.
Working experience and Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
Demonstrated and impactful experience in design control and risk management activities.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.
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.

Responsibilities

Provide Design Quality Engineering support throughout the product development lifecycle ensure compliance with regulations and internal Quality Management System procedures.
Review and evaluate engineering designs, specifications, and technical documents to ensure they align with established standards and best practices.
Facilitate risk management activities including development of Risk Management Plans, Hazard Analyses, Design Failure Modes and Effects Analyses, and Risk Management Reports.
Participate in reviewing design inputs and design output requirements, ensure risk control measures and cybersecurity requirements are transformed into product requirements.
Work closely with engineers to identify and resolve design challenges, offering your guidance and expertise to elevate engineering processes and foster continuous improvement.
Ensure that designs meet functional requirements and manufacturing capabilities.
Work closely with cross-functional teams, such as quality systems, manufacturing and supply chain, to ensure seamless integration of quality into the design process.
Investigate design-related issues, identify root causes, and implement corrective and preventive actions to avoid future occurrences.
Lead the definition and maintenance of the Medical Device File and support the risk management documentation and post-market surveillance processes.
Provide support during Corrective and Preventive Action (CAPA) activities, 3rd party audits, Deviations, Non-conformance, and Complaints - including follow-up on actions and quality department initiatives.
Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).