Senior Quality Assurance Engineer
ŌURA
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $172,550 - $203,000 per year
Job Level
About the role
- Provide oversight for medical device software products through all phases of the development process, risk management, human factors and usability engineering, process development and verification/validation testing, as well as life cycle management during design changes.
- Guide the software development team to define critical safety and performance requirements.
- Lead the compilation, review and approval of all technical documentation for development and risk management documentation, e.g., planning, protocols, reports, risk assessments, testing, etc. by applying applicable company procedures and regulatory requirements.
- Support the timely handling of complaint investigations, change impact assessments, and CAPAs related to the projects under your governance.
- Support continuous improvement to the Quality Management System by identifying areas for improvement and engaging in remediation.
- Collaborate with Oura’s SaMD feature development teams by providing technical and quality support during the development, testing and deployment of software.
- Support internal and external audits and inspections as a subject matter expert.
- Perform a broad variety of tasks in support of the role and responsibilities.
Requirements
- Degree in: Biomedical/Mechanical Engineering or related technical or scientific discipline.
- 8+ years of experience working in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016).
- Working knowledge and application of device regulations (21 CFR 820 and EU MDR 2017/745).
- Expertise in software development and risk management standards (IEC 62304, ISO 14971).
- Experience in applying human factors and usability engineering to medical devices per ISO 62366-1
- Experience with application of risk analysis tools (such as FMEA, or Fault Tree Analysis)
- Experience in conducting clinical evaluations per EU MDR 2017/745.
- Demonstrate ability to assess and provide technical guidance for software as a medical device (SaMD).
- Demonstrate strong skills to organize, prioritize, and execute.
- Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills.
- You can sense and articulate why certain issues demand more diligence to ensure compliance to applicable regulations or standards.
Benefits
- Competitive salary and equity packages
- Health, dental, vision insurance, and mental health resources
- An Oura Ring of your own plus employee discounts for friends & family
- 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
- Paid sick leave and parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
software developmentrisk managementhuman factors engineeringusability engineeringverification testingvalidation testingrisk analysisclinical evaluationsFMEAFault Tree Analysis
Soft Skills
leadershipinterpersonal skillscollaborationcommunicationorganizationprioritizationexecutionattention to detail