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 $12 billion in FY22 and approximately 25,000 people globally working alongside 125,000 global customers, ADI ensures today’s innovators stay Ahead of What’s Possible.

Software Design Quality Engineer / Design History File Manager / Technical Program Manager

Key Functions:

The software design quality engineer is responsible for:

Establishing strategy withing Product development teams ensuring Design Quality engineering to support compliance, integrating with Software development Tools for managing end-to-end product quality and process compliance throughout the Software development life cycle of software medical devices and Digital Health Products.
Participates in the review of Design History File deliverables throughout all phases of Design Control and during the product lifecycle development of software medical device and Digital health products
Generate planning documents for software deliverables during Design Control phases, support the Product and Projects team to create and maintain documentation that outlines the quality standards, processes, and procedures. This includes developing Requirements, Design documents, test plans, test cases, and test scripts, as well as creating reports that document the results of testing activities.
Ensure compliance to ISO 13485, Design Controls, IEC 62304 and SDLC process throughout the development process
Mentor, and coach teams in the creation of Project deliverables required for FDA submissions and ensuring compliance to Design Control including but not limited design and development plans, Risk Management Plan and Configuration, SOUP documentation, integration, verification and validation plans, software requirements, specifications, design documents, design reviews, Traceability, reports, DHF, DMR and DHR.
Conduct Change Review Board Meetings for software Design Changes. Participates on core teams supporting new product development or major changes
Provides guidance on compliance of software to procedures and standards including cybersecurity and privacy requirements
Responsible for ensuring the development of Cybersecurity documentation to ensure compliance with cybersecurity regulations
Act as a lead for designing and improving the Software development Lifecyle process supporting Software medical devices and Digital health products deployed on cloud platform
Support Audits and Inspections as Subject Matter Expert (SME) of Product Program activities and deliverables involving Design Controls, SDLC, Verification &Validation, Defect Management, CAPA, Risk Management and more
Work with various departments and stakeholders within organization to ensure the needed support for the completion of product development activities and deliverables

Required Background and skills

Must have more 10-12 years of experience as DQE, QA, Program manager or Project Manager in FDA QSR and EU MDR regulated medical device industry. Applicants demonstrating experience with commercialization in a small start-up environment are highly desirable.
Bachelor of Science degree in Computer Science, Software, Engineering, Systems Engineering or related field.
Strong experience in Digital Health and Cloud Platform
Applicant must possess excellent problem-solving, troubleshooting, and communications skills.
Class II Medical Device, SaMD, SiMD, Design Controls, SDLC and Risk Management experience.
Experience developing QMS procedures including Software Development Lifecycle,
Experience in Computer systems validation
Strong Product Design, Development, Troubleshooting experience. Working knowledge of risk management, hazards analysis, corrections and recalls, defect management
Experience applying ISO 13485, 14971, IEC 62304, 60601-1 standards to a complex product. Able to demonstrate working knowledge of 21 CFR 820 compliant Quality System.
Experience engaging with internal and external auditors

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: Experienced

Required Travel: Yes, 10% of the time

Shift Type: 1st Shift/Days