Instrument Design QA Lead at Neko Health

The role

The Instrument Design QA Lead oversees the quality and compliance of medical device hardware and firmware for specific product families. This role ensures all designs meet regulatory standards from initial input through final design transfer to support preventative healthcare technology.

What you'll do

• Lead risk management activities according to ISO 14971 standards
• Drive design controls including verification and validation strategies
• Manage the assessment and documentation of medical device changes
• Coordinate design transfer processes with manufacturing and production teams
• Prepare technical documentation for EU MDR and FDA regulatory submissions
• Serve as the subject matter expert for internal and external quality audits

What you'll bring

• Degree in engineering or a related technical discipline
• Minimum five years of medical device industry experience with hardware or firmware
• Expertise in ISO 13485, ISO 14971, EU MDR, and FDA regulations
• Working knowledge of IEC 60601-1 and IEC 62304 standards
• Proficiency with AI-driven workflows and modern digital quality management tools

Your impact

You will ensure that all medical devices reaching members are safe and effective by embedding quality into the engineering process from the start. By establishing audit-ready design history files and efficient change control cadences, you directly enable the company's mission to shift healthcare toward early prevention.