Can you imagine making sure life‑critical medical devices are safe, compliant and ready for the real world? 🩺🔬

Lead the verification and validation activities for safety-critical medical devices in a highly regulated environment. As the Verification & Validation Lead, you will define risk-based V&V strategies, coordinate multidisciplinary teams, manage EMC verification campaigns with accredited laboratories, and ensure compliance with medical device regulations and quality standards. Acting as the central point of contact for V&V activities, you will drive successful product verification, certification, and release while promoting continuous improvement across testing processes.

At ERNI, you are never just a number. You will work in interesting projects, and you will feel part of the team, always supported.

How do we make this happen? 🤔

With people. Besides your team and manager, you will have several support figures like a godparent, who will help you with the practical and administrative aspects of daily life during your first 6 months.

And the second most important person after you, your mentor, who will guide you through your entire onboarding and career at ERNI. You will have regular 1:1 meetings with them, and recurrently, you will work on your development plan to define your short-, medium-, and long-term goals.

At ERNI, we highly value experience and technical knowledge. As a senior profile, you will have the space to continue growing, whether by deepening your technical skills or having greater influence on project decisions, with autonomy and the opportunity to share knowledge with other experts.

And if you are interested in mentoring, there is also space for that: supporting other ERNIans while still focusing on the technical excellence that sets us apart.

What you will bring 🤝

• Bachelor's degree in Electrical Engineering, Electronics, Embedded Systems, Computer Science, Medical Engineering, or a related technical discipline.

• Several years of experience leading Verification & Validation, Quality Assurance, or Systems Engineering activities for embedded or complex technical products.

• Strong knowledge of verification planning, requirements traceability, defect management, and EMC testing and compliance.

• Hands-on experience with laboratory equipment, including oscilloscopes, spectrum analyzers, preamplifiers, EMC measurement equipment, and debugging tools.

• Experience with electronic hardware debugging, including soldering, PCB rework, and implementing hardware modifications on prototype and development boards.

• Professional proficiency in English with demonstrated technical leadership, project management, and analytical problem-solving skills.

• Knowledge of Medical Device EMC Standards: IEC 60601-1-2, IEC 60601-1, CISPR 11 and IEC 61000-4 Series.

Nice to have:

• Experience in medical device development or other highly regulated industries (MDR, IVDR, FDA, or similar environments).

• Knowledge of ISO 13485, ISO 14971, IEC 60601-1, and IEC 60601-1-2 standards.

• Experience coordinating EMC certification campaigns with accredited testing laboratories.

• Familiarity with ALM, requirements management, and test management tools.

• German language skills and experience working in international, cross-functional engineering organizations.

• ISTQB, IEEE or iNARTE for EMC Engineer, or similar professional certification.

You will be responsible for

• Define, plan, and lead the overall Verification & Validation strategy for complex medical device projects.

• Develop risk-based verification plans, test strategies, and acceptance criteria aligned with regulatory and project requirements.

• Manage the planning, execution, tracking, and reporting of all V&V activities across the product lifecycle.

• Ensure end-to-end traceability between requirements, risks, verification activities, defects, and test results.

• Lead EMC verification activities, including pre-compliance testing, compliance campaigns, and coordination with accredited laboratories.

• Analyze verification and EMC test results, assess compliance risks, and drive corrective actions with development teams.

• Oversee laboratory operations, including management of Devices Under Test (DUTs), test environments, and verification assets.

• Ensure calibration, maintenance, and continuous improvement of laboratory infrastructure and measurement equipment.

• Lead cross-functional engineering teams and act as the primary technical interface for V&V activities with internal and external stakeholders.

• Drive continuous improvement of verification methodologies, quality standards, and testing processes to support successful certification and product release.

What if the project ends? 😅

We work on a wide variety of projects, technologies, and sectors, allowing you to keep growing in different environments. If a project ends or you feel ready for a new challenge, we’ll find another one that aligns with your professional development.

Our working model 👩‍🔬

We ask you to be available for key meetings. Need to leave for a doctor’s appointment or to pick up your child from school? No problem. We trust you to deliver quality work within your 40-hour workweek.

Our model is hybrid: we usually go to the office 2 days a week, but we love seeing each other’s faces; the best stories always happen in the office!

You will also enjoy:

🎓 We cover your certifications and reward technical achievements up to €1,400.

🏥 Private health and travel insurance.

💯 Full coverage for sick leave + 1 extra day off per month without medical leave.

🧘‍♀️ Free emotional, legal, and family support.

🏋️‍♀️ Gym discounts + sports compensation.

💳 Flexible remuneration: meals, transport, childcare, etc.

🤝 Referral bonuses: up to €6,000 per candidate and €5,000 per client.

🌴 23 working days of vacation.

🗣️ Free language courses: English, Spanish, Catalan and German.

And the salary? 💸

We will discuss it during the first call. If it is important to you, feel free to ask! 💬

WOULD YOU LIKE TO BECOME AN ERNIan? APPLY NOW! 🚀