Senior Staff Engineer - Design QA - Hardware and Embedded SW

March 28

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Logo of Diabetes Youth Families

Diabetes Youth Families

Diabetes Youth Families is a company that provides wearable insulin delivery solutions for diabetes management. Their primary products, such as the Omnipod 5 and Omnipod DASH systems, offer tubeless and automated insulin delivery for people with Type 1 and Type 2 diabetes, allowing users to manage their condition without the need for multiple daily injections. The systems integrate with continuous glucose monitoring (CGM) devices and can be controlled via compatible smartphones, enhancing the freedom and lifestyle of individuals living with diabetes. With a focus on reducing the burden of diabetes management, they offer financial assistance, support resources, and trial programs to help users adapt to their innovative solutions. The company emphasizes making life simpler while managing diabetes through technology-driven insulin management systems.

πŸ“‹ Description

β€’ Technical Lead for Design Assurance and Quality Engineering activities β€’ Ensuring compliance with applicable standards for medical devices β€’ Oversight and support for Design History File deliverables β€’ Subject Matter Expert for Risk Management Activities β€’ Support for cybersecurity risk management

🎯 Requirements

β€’ BS degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, Physics, or Science degree β€’ A minimum of 8 years work experience in Design Assurance/Quality/Product Design and Development β€’ Subject Matter Expert in Design Controls (FDA 21 CFR Part 820) β€’ Proficient with Medical Device regulations (IEC 62304, ISO 14971, IEC 62366, IEC 60601) β€’ Excellent project team skills and collaborative experience

πŸ–οΈ Benefits

β€’ 100% remote working arrangements β€’ Flexible work hours β€’ Collaboration with cross-functional teams β€’ Opportunities for professional growth

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