Instrument Design QA Lead

The role

The Instrument Design QA Lead owns the quality of medical device hardware and firmware for the Skin, Heart, and Tissue product families. You will ensure safety and performance from design input through design transfer by enforcing design control procedures.

What you will do

• Quality assure design controls across the product lifecycle.
• Review and approve verification and validation plans and results.
• Lead design reviews and risk management for the product family.
• Own the ISO 14971 lifecycle from hazard identification to benefit-risk analysis.
• Facilitate and quality assure change management.
• Coordinate design transfer with Manufacturing QA and Production Engineering.
• Quality assure technical documentation and the medical device file under EU MDR and FDA QMSR.
• Act as QA subject matter expert in internal and external audits.
• Participate in post-market surveillance and coordinate corrective and preventive actions.
• Lead continuous improvement using modern QA tooling and AI-assisted documentation.

Required qualifications

• 5+ years of experience in the medical device industry with a focus on hardware, firmware, or electrical equipment.
• BSc or MSc in engineering, biomedical engineering, systems engineering, physics, or equivalent technical discipline.
• Deep expertise in design controls and risk management.
• Hands-on experience of EU MDR (2017/745), ISO 13485, ISO 14971, and FDA 21 CFR Part 820 / Part 11.
• Strong working knowledge of IEC 60601-1, IEC 62471, IEC 62304, IEC 62366, and ISO 10993.
• Systems engineering mindset.
• Self-leading and decision-capable.
• Fluent English (written and verbal).
• Strong project management and cross-functional coordination skills.
• Genuine fluency with AI-driven workflows and modern digital tooling including eQMS, automation, and AI-assisted documentation.

Nice to have

• Experience with Notified Body interactions and regulatory submissions.
• Audit experience, internal and external.
• Knowledge of firmware development and embedded systems.
• Background in high-growth technology companies or startups.
• Active participation in medical device industry organisations or standards committees.
• Swedish language skills.

About the company

Neko is redefining prevention by making data-driven, preventative care accessible through proprietary technology and direct clinical care.