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Senior Engineering Program Manager (SaMD)

WHOOP

WHOOP

Operations
Boston, MA, USA
Posted on Thursday, April 13, 2023
At WHOOP, we're on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.
As a Senior Engineering Program Manager (SaMD) at WHOOP, you will be responsible for managing the execution of our software as a medical device (SaMD) initiatives, working closely with cross-functional teams, including engineering, product, legal & regulatory, data science, and hardware. You will be responsible for driving cross-functional collaboration, resolving program issues, and ensuring that SaMD initiatives are delivered on time, on budget, and with the required level of quality.

RESPONSIBILITIES:

  • Drive cross-functional collaboration across engineering, product, legal & regulatory, data science, and hardware so that SaMD initiatives are properly prioritized and aligned with business objectives
  • Monitor and control program cost, schedule, performance, scope, and risk to ensure SaMD initiatives are delivered on time and within budget
  • Create and maintain program plans in close coordination with Product and Engineering Managers, including timelines, budgets, change logs, and risk mitigation plans
  • Identify, monitor, and resolve program issues, including resource conflicts, scope changes, and timeline adjustments
  • Ensure compliance with regulatory requirements for SaMD, including FDA 510(k) clearance and ISO 13485 certification
  • Communicate key developments, updates, and risks to SaMD stakeholders in a timely manner
  • Drive continuous process improvement within the engineering organizations, including developing and implementing best practices, standards, and procedures for SaMD program management
  • Adapt and evolve to the needs of the team through the project or program lifecycle
  • Mentor and guide other program managers within the engineering organization

QUALIFICATIONS:

  • Bachelor's or master's degree in engineering, computer science or a related field
  • Experience in engineering program management, with a proven track record of delivering complex medical device initiatives across Hardware, Firmware, Software, and cloud components
  • Experience launching and managing FDA, CE Mark, Health Canada and/or other international SaMD approval processes
  • Strong analytical and problem-solving skills, with the ability to think strategically about complex technical challenges
  • Strong communication and collaboration skills, with experience working with stakeholders at all levels of the organization
  • Experience with SaMD development, including FDA 510(k) clearance and ISO 13485 certification
  • Experience with agile methodologies
  • Excellent project management skills, including the ability to manage multiple projects simultaneously.
  • Experience with wearable devices, cloud technologies, distributed systems, mobile app development and/or microservices architectures is a plus
  • Scrappy and resourceful. When something needs to get done, you find a way to make it happen
  • Experience working in a fast startup environment
  • Passion for health and fitness
This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility