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Neko Health

Verification & Validation Lead

Hybrid Engineering
Added
1 day ago
Location
Type
Full time
Salary
Not Specified

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Related skills

electrical safety emc mdr v&v fda

Neko Health is a Swedish health-tech company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Our vision is to create a healthcare system that can help people stay healthy through preventive measures and early detection. Neko has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is both convenient and affordable for the public. This requires completely reimagining the healthcare experience and incorporating the latest advances in sensors and AI. We are a remote first company, but the company is based in Stockholm and has over 300 employees across Europe.

We are currently seeking an experienced

Verification & Validation Lead

 to join our multidisciplinary engineering team. In this role, you will take ownership of the verification and validation (V&V) activities throughout the entire product lifecycle - from concept to certification and market release. You will define and drive the V&V strategy, ensuring that our medical devices meet the highest standards of safety, performance, and regulatory compliance.

Responsibilities

  • Lead and coordinate all V&V activities across development phases to ensure compliance and product readiness.
  • Translate system requirements into clear, testable verification and validation plans with full traceability.
  • Oversee system-level and end-to-end testing, including EMC, electrical safety, and certification with external partners.
  • Maintain and improve standardized test methods, documentation templates, and reporting practices.
  • Identify and implement automation or infrastructure improvements to streamline testing workflows.
  • Ensure adherence to internal SOPs and contribute to the creation of new guidelines where needed.
  • Represent V&V in design reviews, product changes, and regulatory submissions (e.g. MDR, FDA).

    • Requirements

  • Solid track record leading V&V in regulated product development, preferably within medical devices.
  • Strong understanding of IEC 60601 and related standards for electrical safety and certification.
  • Hands-on experience with system-level testing, including EMC, safety, and environmental validation.
  • Proven ability to manage collaboration with external test houses and certification bodies.
  • Familiar with regulatory frameworks such as FDA, MDR, and ISO 14971.
  • Skilled in developing V&V strategies, ensuring full traceability, risk-based testing, and compliance documentation.
  • Effective cross-functional communicator, able to work seamlessly with hardware, firmware, software, and quality teams.
  • Excellent written and verbal communication in English.
  • Degree in Engineering or equivalent technical discipline.

    •

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