Quality Assurance Engineer

New York, New York, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Health Technology, Wearable TechnologyIndustries

Requirements

Candidates should possess a degree in Biomedical/Mechanical Engineering or a related technical/scientific discipline, with over 3 years of experience in a regulated medical device Quality Management System (21 CFR 820 or ISO 13485:2016). A working knowledge of device regulations (21 CFR 820 and EU MDR 2017/745), expertise in software development and risk management standards (IEC 62304, ISO 14971), and experience applying human factors and usability engineering per ISO 62366-1 are required. The role also necessitates experience with risk analysis tools (e.g., FMEA, Fault Tree Analysis), the ability to assess and guide Software as a Medical Device (SaMD), strong attention to detail, leadership skills, and excellent interpersonal, collaboration, and communication abilities.

Responsibilities

The Quality Assurance Champion will oversee medical device software products throughout their lifecycle, including development, risk management, human factors, usability engineering, process development, verification/validation testing, and design changes. This role involves guiding software development teams to define critical safety and performance requirements, leading the compilation and approval of technical and risk management documentation, and supporting complaint investigations, change impact assessments, and CAPAs. The position also requires supporting continuous improvement of the Quality Management System, providing technical and quality support to SaMD feature development teams, and acting as a subject matter expert during internal and external audits and inspections.

Skills

Quality Assurance

Medical Device Software

Regulatory Compliance

Risk Management

Human Factors Engineering

Usability Engineering

Verification and Validation Testing

Software Development Lifecycle Management

Requirements Definition

Cross-functional Collaboration

Oura

Wearable health monitoring smart ring

About Oura

Oura offers a smart ring that tracks various health metrics, including sleep patterns, heart rate variability, and physical activity. The ring uses advanced sensors to collect data, which is then analyzed and displayed through a mobile app, providing users with insights to improve their health and lifestyle. Unlike many competitors, Oura focuses on a direct-to-consumer model, selling its rings through its website and collaborating with sports teams and health institutions for additional partnerships. The goal of Oura is to help users, including athletes and those with health conditions, optimize their health through data-driven insights.

Oulu, FinlandHeadquarters

2013Year Founded

$344.1MTotal Funding

SERIES_DCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Competitive salary & equity packages

Health, dental, financial, & vision insurance

Wellness & mental health benefits

$300 per month health improvement related stipend

Flexible working hours

An Oura Ring of your own

Employee discount for friends & family

20 days of PTO

Risks

Increased competition from Samsung and Huami may pressure Oura's market share.

Criticism of cumbersome interfaces could lead users to competitors like VIV Health.

High valuation may lead to investor pressure for rapid growth, risking strategic missteps.

Differentiation

Oura's smart ring tracks over 20 biometrics, offering comprehensive health insights.

The ring's seamless wearability and precise monitoring set it apart in the market.

Oura's partnerships with sports teams validate its utility and accuracy for athletes.

Upsides

Oura raised $550M, boosting its valuation to $5.2 billion in 2024.

Integration with AI-driven insights could enhance personalized health recommendations.

Strategic partnerships with Dexcom and Essence Healthcare expand market reach into healthcare.

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