Lead PM, Project / Program Management (Eng)

Analog Devices•Wilmington, MA

1d•$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 Rate of Pay: $153,083.75 - $208,750.00 per year Duties: 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. Partial telecommute benefit (2 days/week WFH). 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. Must also possess the following (quantitative experience requirements not applicable to this section): 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; and DE designing medical devices, generating design history file documents, and managing design transfers from R&D to manufacturing. Contact: Eligible for employee referral program. Apply online at https://www.analog.com/en/about-adi/careers.html and Reference Position Number: R260363 . 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: No Shift Type: 1st Shift/Days 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. 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). Come join ADI – a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to collaborate on solving complex problems that matter from autonomous vehicles, drones and factories to augmented reality and remote healthcare. ADI fosters a culture that focuses on employees through beneficial programs, aligned goals, continuous learning opportunities, and practices that create a more sustainable future.

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.