Cleanroom Operator - Medical Devices

A commercial product. A new cleanroom. A scaling team.

Xeltis is scaling up commercial manufacturing of its CE-marked vascular implants, and we are hiring experienced Cleanroom Operators to help us do it. You will produce our aXess™ vascular access graft in a newly built ISO Class 7 cleanroom at High Tech Campus Eindhoven, working to GMP and ISO 13485 standards in a growing production team.

Our flagship product has achieved CE marking and is moving from clinical stage into commercial-scale production. That means real volumes and real patients on haemodialysis who depend on what leaves our cleanroom. Rather than stepping into an established production line, you will help shape how our new facility operates from day one.

If you have built medical devices or other high-precision products in a regulated environment, take pride in your work, and want to be early in a ramp-up rather than a cog in an established line, this is the moment to join.

As a Cleanroom Operator you will manufacture high-quality medical devices while ensuring full compliance with GMP and quality standards. Your responsibilities will include:

• Manufacturing vascular implants in an ISO Class 7 cleanroom environment.

• Performing precision manual assembly and operating production equipment according to approved procedures.

• Executing in-process controls (IPC) and accurately documenting manufacturing activities.

• Maintaining complete, audit-ready batch records and production documentation.

• Working closely with Quality Control and Quality Assurance on inspections and product release.

• Identifying opportunities to improve process, quality, and efficiency as production volumes increase.

• Supporting the onboarding and training of new colleagues as you progress into a more senior role.

Essential

• MBO Level 4 qualification (or equivalent).

• Minimum 2 years of experience in a regulated manufacturing environment, such as:

  • Medical devices

  • Pharmaceuticals

  • Biotechnology

  • GMP-regulated production

  • ISO 13485 environments

• Hands-on experience with production documentation, batch records, and deviation management.

• Excellent manual dexterity and attention to detail that does not switch off.

• A strong sense of ownership: you flag and escalate quality concerns before they become deviations.

• Good communication skills and working proficiency in English (production language).

Strongly preferred

• Commercial medical device manufacturing experience.

• Experience producing implants, grafts, stents, or other implantable products.

• Product inspection or quality control experience.

• English and Dutch language skills.

• Competitive salary depending on experience.

• Permanent position within a rapidly growing MedTech company with a CE-marked product and a clear commercial roadmap.

• A brand-new, state-of-the-art production facility at High Tech Campus Eindhoven.

• Clear career progression.

• 25 vacation days.

• Pension scheme.

• Travel allowance.

• An international and collaborative working environment where your craftsmanship is seen.

With CE marking achieved for our aXess™ vascular access graft, Xeltis is entering an exciting phase of commercial growth. The products that change patients’ lives are manufactured right here in Eindhoven.

Ready to make a real impact? Apply directly, or contact Felix Bindels, HR Business Partner, at recruitment@xeltis.com. We aim to respond to every application within one week.

Applications in Dutch are also welcome.

Acquisition by recruitment agencies is not appreciated.