Senior Technical Project Manager, Medical Devices

19 hours, 13 minutes ago
Full-time
Senior
Software Development
OURA

OURA

Oura Ring: The world's first wellness ring for accurate sleep and activity tracking, empowering users to make optimal daily choices for improved performance and well-being.

Health Care Providers & Services
251-1K
Founded 2013
$159M raised

Description

  • Own technical project management for regulated software programs, including timelines, resourcing, and leadership communications.
  • Facilitate meetings and ensure program deliverables are identified and completed on time.
  • Serve as liaison between development teams and Quality Assurance throughout the software development lifecycle for SaMD.
  • Drive the Software as a Medical Device (SaMD) Design History File (DHF) across multiple concurrent programs.
  • Collaborate with product and software developers to provide technical and quality support during design, development, testing, and deployment.
  • Provide technical domain support to help define critical safety and performance requirements.
  • Lead the creation, review, and approval of technical and risk management documentation, including planning, traceability matrices, protocols, reports, risk assessments, and testing documentation.
  • Perform additional tasks in support of program and regulatory responsibilities.

Requirements

  • 6+ years of project management experience in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016).
  • Experience managing a product or device through the full lifecycle end to end.
  • Degree in Biomedical, Computer Science, or a related technical or scientific discipline.
  • Demonstrated ability to assess and provide technical guidance for software as a medical device (SaMD).
  • Ability to understand and connect architecture across app, cloud, IT, algorithms, and firmware contexts.
  • Strong ability to organize, prioritize, and execute.
  • Ability to motivate teams and communicate the importance of DHF documentation to stakeholders unfamiliar with it.
  • Detail-oriented with strong leadership, collaboration, and communication skills.
  • Experience working with people from different cultures and backgrounds, with high emotional intelligence and empathy.
  • Ability to recognize when issues require greater diligence to ensure compliance with applicable regulations or standards.
  • Understanding of regulatory inspections and interaction with regulatory authorities.
  • Experience with consumer software products or services is highly valued.

Benefits

  • Lunch benefit.
  • Wellness benefits.
  • Statutory accident insurance plus additional free time insurance.
  • Travel insurance for both business and leisure.
  • Occupational healthcare.
  • Wellness Time Off.
  • An Oura Ring and lifetime Oura membership.

Interested in this position?

Apply directly on the company website

Apply Now

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