ViCentra · Utrecht, Utrecht, Netherlands
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Posted 22 days ago
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likely hiring — 18 active listings
🌍 Making Every Move Matter
At ViCentra, we’re on a mission to make living with diabetes easier, by designing simple, beautiful, and effective solutions that fit people’s lives, not the other way around. We combine technological innovation with human-centered design to empower people with more freedom, confidence, and life on their terms. Our values; Be Bold, Build Trust, Focus on the Customer and Deliver Excellence drive everything we create and every decision we make.
We believe that when ambition meets purpose, remarkable things happen. If you thrive in a space where ideas accelerate, challenges spark growth, and making a difference is the goal, ViCentra is your next great adventure. 🚀
👩💻 Your Impact
ViCentra is at a defining moment, scaling across Europe and entering the US market with the Kaleido ecosystem. The devices we build will live on people's bodies, every hour of every day, for years. That's a promise only rigorous testing can keep.
As Lead Test Engineer, you are the person who makes that promise real. You will build ViCentra's in-house testing and reliability capability from the ground up, owning the protocols, the rigs, and the evidence base that prove our devices perform, endure, and stay safe long after launch. This is where engineering conviction meets patient trust, and it starts with you.
Your impact lies in driving the documentation for test protocols and reports around testing to be of the highest quality. You will define how mechanical, 60601 and EMC testing evidence is generated, documented, and maintained, ensuring that once products are launched, ViCentra has a robust, compliant testing framework it fully owns.
Within your first six months, you will establish (FDA‑ready) mechanical test protocols that not only support approval, but also enable ongoing changes, updates, and improvements with confidence. Your work ensures that innovation doesn’t stall after launch, it moves forward safely, compliantly, and at speed.
In short, your impact is about taking what has been built and making it future‑proof. Giving teams, regulators, and users confidence that ViCentra’s devices are engineered, tested, and maintained to the highest standards.
🔧 What You’ll Take On
You will lead from a technical perspective, with a strong emphasis on documentation, structure, and coordination:
Own and author mechanical and EMC test protocols and procedures, written to meet FDA/MDR submission and review standards
Coordinate mechanical, software, and EMC testing, including planning, execution oversight, review, and documentation
Act as the technical testing authority across R&D, Quality, Regulatory, and external test houses
Ensure high‑quality test documentation, reporting, and traceability across projects
Balance hands‑on testing with coordination with approximately 80% focus on documentation & project management and 20% hands‑on execution.
Support the growth of a Test team, leading through technical expertise.
Ensure testing activities align with medical device regulations, relevant standards, and internal quality systems
📌 What You Bring
6+ years of experience in testing, verification, or validation within the medical device industry
Proven experience writing mechanical test protocols and procedures for regulatory submissions
Strong understanding of FDA expectations and documentation requirements for U.S. market approval
Solid background in mechanical testing, with familiarity using basic mechanical test tools
Experience coordinating and working with external test laboratories, including EMC testing
Comfortable in a role where documentation, planning, and coordination are core responsibilities
Technically strong, detail‑oriented, and confident leading from expertise
Clear and effective communicator across disciplines
💡 Life at ViCentra
Working at ViCentra means joining a team defined by:
Courage to create: We experiment, challenge norms, and learn fast.
Trust above all: Integrity, honesty, and openness shape our relationships.
Customer-first mindset: Every idea is measured by the impact on those we serve.
A drive for excellence: We hold ourselves to the highest standard because lives depend on it.
Our days move fast, fuelled by curiosity, diverse perspectives, and a love for collaboration. Here, you can shape and be shaped by groundbreaking work in MedTech.
🌱 Grow With Purpose
Harness your talent for a mission that truly matters.
Enjoy creative freedom, supportive teamwork, and room to lead initiatives.
Make a direct impact in people’s lives, today and into the future.
Be surrounded by innovators who challenge and cheer you on.
🌏 Every Journey Starts Somewhere — Make Yours Count Here
We believe a powerful team is built on unique backgrounds and points of view. If this opportunity excites you but you’re unsure if you fit every bullet, we want to hear your story. At ViCentra, it’s your potential and passion that catch our eye.