Instrument Design QA Lead

Role Purpose

As the Instrument Design QA Lead, you will own the quality of Neko’s medical device hardware and firmware across a dedicated product family (Skin, Heart, Tissue): that what we build is safe, that it performs as intended, and that we can show it, from first design input through to design transfer. Regulatory compliance follows from getting that right; it is not the point of the job.

You hold authority to approve or reject quality deliverables and to enforce design control procedures. The engineering teams build and own their designs and their changes; your job is to make sure safety and quality are engineered in from the start rather than demonstrated after the fact, and to say so plainly when they are not.

You will be part of a small, high-trust Quality team, working closely with hardware and firmware engineers, operations, and regulatory leads across an expanding product portfolio.

What You’ll Do

• Quality assure design controls across the product lifecycle, reviewing and approving verification and validation plans and results, and keeping design inputs, outputs and traceability coherent across the family.

• Lead design reviews and risk management for your product family, owning the ISO 14971 lifecycle from hazard identification through residual risk evaluation and benefit-risk analysis, with a pragmatic and engineering-driven approach.

• Facilitate and quality assure change management, with the engineering teams driving their own design and medical device changes and you making sure each one is properly assessed, documented, reviewed and approved.

• Coordinate design transfer with Manufacturing QA and Production Engineering, moving designs into manufacturing with the evidence and controls in place.

• Quality assure the technical documentation and medical device file for your product family, keeping them complete, current and audit-ready under EU MDR and the FDA QMSR.

• Act as QA subject matter expert in internal and external audits, covering design quality, design controls and design transfer.

• Participate in post-market surveillance, identifying design-related issues and coordinating corrective and preventive actions.

• Lead continuous improvement, using modern QA tooling, AI-assisted documentation and automated testing to raise quality and development speed together.
  

Who You Are

• 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, with 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, 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.
  

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.
  

Why Join Us?

You will own quality for a product family that goes into real clinics and produces real health data for real people. The team is small enough that your judgement carries, and close enough to engineering that you see the effect of it.

If you think quality is something you engineer in rather than inspect at the end, we would like to talk to you.