About the job
Our Mission
At Neko Health, we are pioneering a transformative approach to healthcare, shifting the focus from treating illnesses to preventing them. Utilizing cutting-edge, non-invasive technology combined with clinical expertise, we provide early and actionable health insights that empower individuals to take control of their well-being.
Your Role
As the Instrument Design QA Lead, you will play a pivotal role in ensuring the quality and compliance of our medical device hardware and firmware across a dedicated product family. Your primary responsibility will be to guarantee that all our builds adhere to rigorous regulatory standards from initial design through to final transfer.
This position is critical; you will have the authority to approve or reject quality deliverables, enforce design control procedures, and embed compliance throughout the development process, ensuring safety and effectiveness in every device we produce.
Joining our intimate, high-trust Quality & Regulatory team, you will collaborate closely with hardware and firmware engineers, operations, and regulatory leads as we expand our product offerings.
Your First 6-12 Months
- Assume full QA ownership of a product family (Skin, Heart, Tissue), managing design controls, risk management, and change management to comply with ISO 13485, EU MDR, and FDA regulations.
- Resolve the backlog of Medical Device Changes and establish a robust change control process that aligns with the engineering team's pace.
- Integrate QA into all relevant Engineering Epics to ensure no product development proceeds without active QA oversight.
- Produce an audit-ready design history file and comprehensive technical documentation for your assigned product family.
Your Responsibilities
- Lead risk management initiatives following ISO 14971, applying a practical, engineering-focused approach to identify, evaluate, and mitigate risks.
Manage the complete risk management lifecycle for your product family, from hazard identification through to residual risk evaluation and benefit-risk analysis.
- Drive design controls throughout the product lifecycle.