Lead Mechanical Test Engineer

Overview
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 and provide 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.

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 is a promise only rigorous testing can keep. As Lead Test Engineer, 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.

You will drive the documentation for test protocols and reports to be of the highest quality, defining how mechanical, EM 60601, and EMC testing evidence is generated, documented, and maintained, ensuring a robust, compliant testing framework.

Within your first six months, you will establish FDA‑ready mechanical test protocols that support approval and enable ongoing changes, updates, and improvements with confidence. Your work ensures that innovation does not stall after launch; it moves forward safely, compliantly, and  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 the 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.

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