Location: Waalre
Contract: 32–40 hours/week (0.8–1.0 FTE)
Position: Engineering Manager
Department: Engineering
Contact: Tim Thuijs (+31655370343 / tim.t@medicaldevicesrecruitment.com)
About Vivolta
At Vivolta, we don’t just manufacture medical devices: we develop the technologies that make manufacturing them possible. As a CDMO specialized in electrospun medical devices, we work at the frontier of material science, precision engineering, and regulated production. Our engineering team builds and validates the machines, processes, and systems that bring our customers’ innovations from the lab to the patient. We’re looking for an Engineering Manager who wants to lead that work.
The role
As Engineering Manager, you are the operational heart of our engineering department. You lead a multidisciplinary team of ~10 engineers (mechanical, software (PLC), process, and mechanics) and you are responsible for taking projects from concept freeze all the way through to a validated, documented, and fully transferred manufacturing solution. This is not a maintenance role. You will be building and industrializing new manufacturing technologies in a regulated environment, working closely with our CTIO, and collaborating across Business Development, Application Development, Quality, and Operations.
You drive two core engineering domains:
– Machine & Equipment Engineering: designing and validating proprietary manufacturing systems, including our electrospinning machines
– Process Engineering, Scale-up & Validation translating R&D-stage processes into robust, scalable, and IQ/OQ-qualified manufacturing solutions
Your impact is direct and tangible: the manufacturing technologies your team delivers will end up producing medical devices that reach patients around the world.
What you’ll do
– Lead planning, priorities, and resource allocation across engineering projects
– Ensure on-time, on-budget, and on-scope delivery while managing risks, dependencies, and suppliers
– Own engineering documentation within the ISO 13485 design control framework
– Drive qualification and validation activities (IQ/OQ) and structured transfer to operations
– Coach and develop your team: building a culture of clarity, accountability, and high performance
– Translate Vivolta’s business objectives into clear engineering goals and deliverables
– Collaborate with senior leadership on long-term engineering strategy and gate reviews
What you bring
– A Bachelor’s or Master’s degree in a relevant engineering discipline
– At least 5 years of experience in a MedTech or CDMO environment
– Proven leadership experience with demonstrated success in team development
– Hands-on experience with industrialization, validation (IQ/OQ), and structured gate processes
– A solid technical background in mechatronics, automation, or complex machinery
– Proficiency in ISO 13485 design control and risk management methodologies
– Experience managing CAPEX and engineering budgets
– Excellent communication skills in English (Dutch is an advantage).
Who you are
You’re an engineering leader who thrives on complexity and takes ownership. You know how to build teams, set structure, and keep projects moving in a regulated environment without losing sight of the bigger picture. You communicate clearly with both engineers and executives, and you’re driven by the idea that the work you do has real-world impact on patients’ lives.
Why Vivolta?
At Vivolta, innovation drives everything we do. As an Engineering Manager, you will have a direct impact on both technology and people, contributing to life-changing medical solutions. We offer:
– A key leadership role at a growing, innovative MedTech CDMO. This is technically challenging environment where no two projects are the same.
– Excellent secondary benefits, such as pension, 25+ days off and 5 ADV days and a company lease-a-bike option.
– Development opportunities through training and/or courses, both in-house and external.
– A professional yet fun workplace with passionate colleagues and “state-of-the-art tooling” tooling and equipment.
– Team-building activities that support both professional growth and workplace enjoyment
– Unique perks such as Stock Appreciation Rights (SARs) upon transition to a permanent contract.
– A long-term career perspective within a fast-growing MedTech company.
Interested or questions?
Feel free to contact our recruiter Tim Thuijs at +31655370343 or tim.t@medicaldevicesrecruitment.com.
Or apply via the form on our website.
Heads up!
Please note: We are building our team directly and are not engaging with external recruitment agencies at this time.
Also, please note that Vivolta is not a recognized sponsor for visa applications. This means we’re currently only able to consider candidates with a valid EU work permit.
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