Senior Technical Project Manager, SaMD

New York, New York, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Health Tech, Medical Devices, SoftwareIndustries

Requirements

Candidates must have over 5 years of experience in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016) as a project manager. A degree in Biomedical/Computer Science or a related technical or scientific discipline is required. Demonstrated ability to assess and provide technical guidance for software as a medical device (SaMD), grasp holistic architecture across different contexts, and possess strong organizational, prioritization, and execution skills are essential. Detail orientation, strong leadership, excellent interpersonal, collaboration, and communication skills, along with an understanding of regulatory inspections and interactions with regulatory authorities, are also necessary.

Responsibilities

The Senior Technical Project Manager will act as a liaison between development teams and Quality Assurance, championing quality through all development phases. They will collaborate with product and software developers on regulated products, providing technical and quality support during design, development, testing, and deployment. This role involves guiding the software development team to define critical safety and performance requirements and leading the construction, review, and approval of technical documentation, including design history files (DHF) and risk management documentation.

Skills

Technical Project Management

Software Development Lifecycle

Quality Assurance

Regulatory Compliance

Medical Device Software

Risk Management

Documentation

Design Controls

Data Science

Agile Methodologies

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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