Instrument Design QA Lead

Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives. Role Purpose As the Instrument Design QA Lead, you will own the quality and compliance of Neko's medical device hardware and firmware across a dedicated product family — ensuring that everything we build meets applicable regulatory standards from first design input to final design transfer. This is not a support function. You hold authority to approve or reject quality deliverables, enforce design control procedures, and ensure that compliance is engineered in from the start — not layered on at the end. Your work directly enables Neko's mission: every device that reaches a member is safe, effective, and built to the highest standard. You will be part of a small, high-trust Quality & Regulatory team working closely with hardware and firmware engineers, operations, and regulatory leads across an expanding product portfolio. What You'll Deliver In The First 6–12 Months

• Take full QA ownership of one product family (Skin, Heart, Tissue) — running design controls, risk management, and change management in compliance with ISO 13485, EU MDR, and FDA requirements.
• Clear the backlog of open Medical Device Changes and establish a functioning change control cadence that keeps pace with the engineering team.
• Embed QA into all relevant Engineering Epics — no product development running without active QA coverage.
• Deliver an audit-ready design history file and technical documentation for your assigned product family.

What You'll Do Lead risk management activities in accordance with ISO 14971 — identifying, evaluating, and controlling risks with a pragmatic, engineering-driven approach. Own the full risk management lifecycle for your product family, from hazard identification through residual risk evaluation and benefit-risk analysis. Drive design controls across the product lifecycle. Including verification and validation strategy, design reviews, design inputs and outputs, and traceability throughout. Own change management. Ensure design changes are properly assessed, documented, reviewed, and approved in compliance with applicable regulations and internal procedures. Coordinate design transfer. Work closely with manufacturing QA Lead and Production Support technical documentation for regulatory submissions. Including Design History Files and Technical Documentation under EU MDR. Lead continuous improvement initiatives. Leveraging modern QA tooling, AI-assisted documentation, and automated testing frameworks to improve quality, compliance, and development speed. Act as QA subject matter expert for internal and external audits. Covering medical device design quality, design controls, and design transfer. Participate in post-market surveillance. Identify design-related issues and coordinate corrective and preventive actions. Minimum Qualifications

• BSc or MSc in engineering, biomedical engineering, systems engineering, physics, or equivalent technical discipline.
• 5+ years of experience in the medical device industry with a focus on hardware, firmware, or electrical equipment.
• Deep expertise in design controls and risk management — hands-on experience with 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 — able to connect and coherently address hardware, firmware, and systems integration across a product family.
• Self-leading and decision-capable; confident operating in a fast-paced, evolving environment with incomplete processes.
• Fluent English (written and verbal) with strong project management and cross-functional coordination skills.
• Genuine fluency with AI-driven workflows and modern digital tooling — eQMS, automation, and AI-assisted documentation are part of how you work, not add-ons.

Preferred

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