Design Quality Engineer II, Digital Health

Posted 1.19.24
Location
Boston, MA
At WHOOP, we’re on a mission to unlock human performance. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives. WHOOP is looking for a Design Quality Engineer II as a core member of the cross-functional Digital Health team at WHOOP.
 
As a Design Quality Engineer II, you will be responsible for various quality functions in support of product development for Medical Software, such as leading Risk Management activities, collaborating with the engineering, product, and clinical teams throughout the SDLC, mentoring team members through Design Controls, and ensuring compliance with the Quality Management System (QMS). You will hold yourself and the team accountable for developing best-in-class, safe, and effective medical devices that address customer and regulatory requirements. Additionally, you will need to bring best practices and creative problem-solving abilities to support high-speed development in a consumer wearable company.
RESPONSIBILITIES:
  • Maintenance of the SDLC process in conformance with US FDA Quality System Regulations, IEC 62304, and ISO 13485 Design Controls
  • Support the Engineering, Product and Clinical teams in the creation and approval of Design History File (DHF) records, including design and development plans, verification and validation plans, software requirements specification, software architecture, design reviews, Cybersecurity records, Risk Management File (RMF), Usability Engineering File and traceability matrices
  • Lead and conduct risk management activities, including system risk analysis and software FMEAs
  • Provide medical device software development expertise for SaMD projects in the areas of Regulatory Compliance, Design Control, Usability Engineering, and Risk Management as needed
  • Support software tool validation efforts
  • Foster organizational compliance to the quality system, including ongoing training and education on software QMS and SDLC frameworks
  • Drive integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes
  • Support QMS improvements and  internal/external regulatory inspections
  • Sustain of SaMD projects, post market/post release support activities
QUALIFICATIONS:
  • Bachelor’s Degree in Engineering, Biomedical Engineering, Computer Science, related technical field, or equivalent practical experience
  • 4+ years of experience in software design quality engineering in the medical device industry
  • Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14791 (Risk Management), AAMI TIR57, ISO 62366
  • Leads by doing and demonstrates leadership and teamwork in a collaborative cross-functional environment
  • Demonstrated history in achieving regulatory market authorization
  • Excellent organizational, interpersonal, verbal, and written communication skills
  • Passion for delivering impactful and high-quality products to people
  • Experience with Consumer Wearable Products, General Wellness Products, Digital Health, mobile medical applications, or Medical Device Data Systems (MDDS) is a plus
  • Experience with Machine Learning medical device technologies in an ambiguous, fast-paced, and innovative environment is a plus.
  • Experience with 60601 is a plus
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