Lead Software Design Quality Engineer (Medical Devices)
Design, Quality Assurance
Boston, MA, USA
Posted on Thursday, April 6, 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.
WHOOP is seeking a Lead Design Quality Engineer (Medical Devices) to navigate and manage regulatory and quality processes in support of product development for Medical Device Software, including the implementation and execution of a Software Development Lifecycle (SDLC) process in alignment with US FDA Quality System Regulations and Design Controls. In this role, you will work with the WHOOP Medical Device Team to act as a champion of Quality Assurance and Regulatory activities throughout the SDLC process.
As a Lead Design Quality Engineer, 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 WHOOP Medical Device Team 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 medical development in a consumer wearable company.
This role reports to the Director of Quality and Regulatory Affairs.
- Lead ongoing implementation and execution of the SDLC process in conformance with US FDA Quality System Regulations, IEC 62304, and ISO 13485 Design Controls
- Act as a Design Quality team member for Software as a Medical Device (SaMD) projects
- Support the Medical Device Team in the creation and approval of Design History Files (DHFs), including design and development plans, verification and validation plans, software requirements specification, software architecture, design reviews, Risk Management File (RMF), 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.
- 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
- Bachelor’s Degree in Engineering, Biomedical Engineering, Computer Science, or related technical field, or equivalent practical experience
- 5+ years of experience in software design quality engineering in the medical device industry
- Deep experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14791 (Risk Management), and IEC 62366 Usability Engineering principles and requirements
- Leads by doing and demonstrates leadership and teamwork in a collaborative cross-functional environment
- Excellent organizational, interpersonal, verbal, and written communication skills
- Passion for delivering impactful and high-quality products to people
- Nice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health, mobile medical applications, or Medical Device Data Systems (MDDS)
- Nice to Have: Experience with Machine Learning medical device technologies in an ambiguous, fast-paced, and innovative environment
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility.
See more open positions at WHOOP
Something looks off?