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Project Manager - Medical Software Security and Compliance

San Jose, CA 95113
  • Healthcare
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  • Biotechnology / Science
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  • Manufacturing / Production
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Job Details


Amazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer electronics. Lab126 began in 2004 as a subsidiary of, Inc., originally creating the best-selling Kindle family of products. Since then, we have produced groundbreaking devices like Fire tablets, Fire TV, Amazon Echo and Amazon Show. The Amazon Devices group delivers delightfully unique Amazon experiences, giving customers instant access to everything, digital or physical.

The Role:

The Senior Project Manager Software Operations, Security, and Compliance is responsible for the management and delivery of the program€™s software deliverables, application and security, and regulatory requirements compliance. This person is responsible for working within the local and remote development and manufacturing sites, engineering and software teams, to define and implement solutions to insure compliance to security and regulatory requirements. Responsibilities are cross functional including security, compliance, software, cloud capabilities, and manufacturing automation solutions. A key superpower must be to work various Technical Program Managers and Development Managers across Amazon business groups to ensure that status is properly reported and mechanisms are in place to report and escalate dependencies between teams. This role needs to understand when to dive deep to keep the project on track. They must set the bar on the ability to discover the true requirements underlying feature requests, recommend alternative technical and business approaches, and drive engineering efforts to meet aggressive timelines. This role needs to clearly and concisely communicate, both verbally and in writing, with senior management on status, risks and required mitigations to maintain project commitments.
It is expected that the individual will be adept at making appropriate trade-offs to optimize time-to-market, clearly communicate goals, compliance and security requirements, and negotiate win-win solutions that support our manufacturing operations and achieve desired outcomes for internal cross-functional and remote project teams.
* Work with diverse Amazon groups to coordinate activities and mitigate issues a minimum amount of escalations to executives.
* Work with corporate and devices security teams to define actionable solutions for security deployment.
* Attend and lead program new product introduction meetings to understand the cost and schedule implication of engineering and/or process changes
* Using JIRA and other tools to track errors and manage deliverables.
* Be able to lead scrums and have a structured Sprint/Story development process.
* Work with the Lab126 Management team to ensure predictable, accurate forecasts for your projects.
*Host weekly executive management cost reviews that deep dive through every aspect of your product cost and schedule.


· Bachelor's Degree
· 5+ years of experience in product or program management, product marketing, business development or technology
· Experience with end to end product delivery
· Experience with feature delivery and tradeoffs of a product
· Experience overseeing roadmap strategy and definition
*Computer Science degree or a technical degree in a related field.
*10+ years of relevant work experience in technical program in the biological sciences, with specific experience in defining projects, collecting requirements, coordinating efforts to scope, schedule, and deploy new features sets
*Working knowledge of medical lab technologies, products and tools preferable. Experience in building out/managing large-scale facilities, including capital equipment, labor, material and capacity planning. Experience setting up certified facilities highly preferred, including FDA, CLIA, ISO. Ability to setup a BOM from scratch, including define a consumables strategy.
* Excellent analytical and communication skills.


· 10+ years€™ experience in operations, throughout the product life cycle from Concept to EOL
· Master€™s degree preferred and/or bachelor€™s degree in bio/medical field & 10+ years experience. Working knowledge of medical lab technologies, products and tools preferable.
· Experience in building out/managing large-scale facilities, including capital equipment, labor, material and capacity planning. Experience setting up certified facilities highly preferred; including FDA, CLIA, ISO.
· JIRA, Confluence experience preferred
· Experience defining and implementing security and compliance solutions
Lab126 is part of the Amazon group of companies and is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
For individuals with disabilities who would like to request an accommodation, please visit

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