Lead PM, Project / Program Management (Eng)

Analog Devices•Wilmington, MA

12h•$153,084 - $208,750•Hybrid

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) . Employer: Analog Devices, Inc. Job Title: Lead PM, Project / Program Management (Eng) Job Requisition: 1010.16.2 / R260363 Job Location: Wilmington, Massachusetts Job Type: Full Time

Requirements

Must have a Master’s degree in Electrical Engineering, Biomedical Engineering, Systems Engineering, or related field of study (or foreign education equivalent) and four (4) years of experience as a Project Manager or related occupation developing and managing digital healthcare products and projects.
Demonstrated Expertise (“DE”) leading the development of new medical devices or consumer healthcare product development programs following FDA Design Controls such as 21CFR820.30 and Quality Systems Policies such as ISO13485 and ISO 62304
DE utilizing various project management methodologies, including waterfall, six sigma, and Agile and project management software including MS Project, Jira, MS Timeline, and Confluence
DE managing multiple projects across cross functional disciplines, such as Marketing, Quality, Engineering, Regulatory, Manufacturing, Clinical, and Operations
DE generating project management documents such as project charter, dashboard, risk management tools, RACI, project and management reviews
DE designing medical devices, generating design history file documents, and managing design transfers from R&D to manufacturing.

Responsibilities

Lead internal and external development teams and cross-functional engineering teams that develop new Vital Signs Monitoring Algorithms, as well as software and hardware projects, from concept to release.
Lead development process in the Systems product line from concept through regulatory approval, or advanced development projects that are important to product line roadmap.
Deliver products to market in scope, on schedule, and within budget targets.
Manage end-to-end product development: software, firmware, hardware, test infrastructure, regulatory, and compliance.
Develop complete project management plan and review efficacy by coordinating with business leadership.
Hold teams accountable and proactively identify risks to project execution.
Use best practices for the Technical Requirements Development, Plan of Record (POR), POR Change Process (PCP), and project shared sites.
Pursue innovative approaches to Time and Cost Analysis, Risk Management, and Technical Requirements Development.
Communicate cross-functional dependencies, project plans, status, and priorities across Engineering, Quality, Regulatory, Manufacturing, and Clinical disciplines to key stakeholders.
Lead the greater project management community through mentorship and leadership in development programs.
Support DHC Systems organization.
Navigate medical device process needs vs. consumer product process needs, ensure compliance with existing processes, and implement necessary tailoring.