Cleanroom Operator - Medical Devices

Xeltis; Eindhoven; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Competitive salary

Permanent position

New facility

Career progression

25 vacation days

Pension scheme

Travel allowance

International team

Job summary

Xeltis is scaling up commercial manufacturing of its CE-marked vascular implants. You will join a newly built ISO Class 7 cleanroom at High Tech Campus Eindhoven, working to GMP and ISO 13485 standards in a growing production team.

As a Cleanroom Operator you will manufacture vascular implants, perform precision assembly, document batch records, and support quality control. The role offers a permanent position in a fast-growing MedTech company with clear career progression and international

Qualifications

• Regulated manufacturing experience in medical devices, pharmaceuticals, biotech or GMP ISO 13485 environments.
• Hands-on production documentation, batch records and deviation management.
• Excellent manual dexterity and meticulous attention to detail.
• Strong sense of ownership and ability to flag quality concerns early.
• Good communication skills in English; production language.

Responsibilities

• Manufacture vascular implants in an ISO Class 7 cleanroom environment.
• Perform precision manual assembly and operate production equipment per procedures.
• Execute IPCs and document manufacturing activities accurately.
• Maintain audit-ready batch records and production documentation.
• Collaborate with Quality Control and Quality Assurance on inspections and release.
• Identify opportunities to improve process quality and efficiency as volumes grow.
• Assist onboarding and training of new colleagues as you progress toward senior roles.

Skills

Manual dexterity

Attention to detail

Ownership

English proficiency

Education

MBO Level 4 qualification (or equivalent)

Job description

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.

What you will do

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.

What we are looking for

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.

What we offer

• 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.

About Xeltis

Xeltis is a leading medical technology company developing restorative vascular implants based on Nobel Prize-winning supramolecular chemistry. Our innovative devices enable the body to regenerate living tissue and restore natural function.

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.

Applications

Applications in Dutch are also welcome.

Acquisition by recruitment agencies is not appreciated.