Process Engineer / Mechanical Engineer / Industrialization Engineer Medical devices.

Vivolta; Waalre, Eindhoven; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Pension

25+ days off + 5 ADV days

Lease-a-bike

Job summary

Vivolta is a fast-growing MedTech company specializing in the contract development and manufacturing of electrospun medical implants. We are launching a production facility and seeking a Process Engineer with a Mechanical Engineering background to own the design, development, validation, and lifecycle management of manufacturing equipment.

You will join the Engineering team at our Waalre HQ and work closely with R&D, Manufacturing, Quality Assurance, and external partners to industrialize

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering, Mechatronics, Biomedical Engineering, or related
• 4–8 years of engineering experience in a product development or manufacturing environment
• Experience with 3D CAD software, preferably
• Experience with product testing, validation, and engineering documentation
• Experience with process validation, equipment qualification and change control
• Strong analytical and problem-solving skills
• Excellent communicator

Responsibilities

• Lead the development, industrialization, validation, and continuous improvement of manufacturing equipment and processes for electrospun medical implants.
• Take ownership of industrializing novel electrospinning technologies and translating concepts into robust manufacturing solutions.
• Analyze process and production data to identify opportunities for yield improvement, process robustness, and operational efficiency.
• Design and develop mechanical components, assemblies, and systems for medical devices.
• Create and maintain 3D CAD models, engineering drawings, and technical documentation.
• Prepare and maintain technical documentation, work instructions, specifications, protocols, reports, and change control documentation.
• Collaborate with external machine builders, suppliers, and integrators during equipment development and implementation.
• Support cleanroom manufacturing operations by ensuring equipment and processes meet environmental and contamination control requirements.
• Support and execute process validation activities, including IQ, OQ, PQ, and process validation protocols.
• Develop, implement and optimize manufacturing processes to improve quality, efficiency, yield, and productivity.
• Participate in risk assessments, non-conformance investigations, continuous improvement activities.
• Ensure compliance with GMP, quality, safety, and regulatory requirements.

Skills

Strong analytical skills

Excellent communicator

Team-player

Structured problem-solving

Education

Bachelor/Master in Mechanical/Mechatronics/Biomedical Engineering

Tools

3D CAD software

Product testing & validation

Engineering documentation

Job description

Location

Waalre / HTC Eindhoven

Contract

32-40 hours/week (0.8-1.0 FTE)

Position

Process Engineer

Department

Engineering

About Vivolta

Vivolta is a fast-growing MedTech company specializing in the contract development and manufacturing of electrospun medical implants. Our manufacturing takes place in a validated cleanroom environment. We support our customers from advanced development up to manufacturing. While operating within a highly regulated environment where quality, compliance, and reliability are central to everything we do.

About the Role

You will be creating manufacturing processes coming from R&D to that scale to manufacturing. We are looking for a Process Engineer with a Mechanical Engineering background to support the design, development, validation, and lifecycle management of manufacturing equipment. As we are launching a manufacturing environment to provide contract manufacturing services, we are looking for someone willing to grow into the role of Process Engineer along with ramping up the production scale. You will have full ownership from design towards manufacturing. In this role, you will contribute to the creation of equipment for electrospinning: an innovative production method to create fiber based medical implants that outperform current state-of-the art products. You will contribute to the development of manufacturing equipment and take the responsibility to optimize, validate, and maintain production processes when the equipment becomes operational. The position is in the Engineering department; you will collaborate closely with R&D, Manufacturing, Quality Assurance, and external partners to develop robust, manufacturing equipment and efficient and compliant manufacturing processes.

Key Responsibilities

Lead the development, industrialization, validation, and continuous improvement of manufacturing equipment and processes for electrospun medical implants, ensuring robust, scalable, and compliant production from concept through commercial manufacturing. Take ownership of industrializing novel electrospinning technologies and translating innovative concepts into robust manufacturing solutions. Analyze process and production data to identify opportunities for yield improvement, process robustness, and operational efficiency. Design and develop mechanical components, assemblies, and systems for medical devices. Create and maintain 3D CAD models, engineering drawings, and technical documentation. Prepare and maintain technical documentation, work instructions, specifications, protocols, reports, and change control documentation. Collaborate with external machine builders, suppliers, and integrators during equipment development and implementation. Support cleanroom manufacturing operations by ensuring equipment and processes meet environmental and contamination control requirements. Support and execute process validation activities, including IQ, OQ, PQ, and process validation protocols. Develop, implement and optimize manufacturing processes to improve quality, efficiency, yield, and productivity. Participate in risk assessments, non-conformance investigations, continuous improvement activities. Ensure compliance with GMP, quality, safety, and regulatory requirements.

What will you bring to the table?

You thrive in an innovative and team-oriented environment, where you can spar with colleagues, exchange ideas, and grow together.

Required Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering, Mechatronics, Biomedical Engineering, or related
• 4-8 years of engineering experience in a product development or manufacturing environment.
• Experience with 3D CAD software, preferably
• Experience with product testing, validation, and engineering documentation.
• Experience with process validation, equipment qualification and change control.
• Strong analytical and problem-solving skills.
• Excellent communicator

Preferred Qualifications

• Knowledge of FDA design controls, ISO 13485, and regulated product development processes.
• Experience with Lean Manufacturing, Six Sigma, or Operational Excellence methodologies.
• Knowledge of GMP and regulated manufacturing environments.

Competencies

• Team-player
• Strong (technical) ownership
• Collaboration across multidisciplinary teams
• Structured problem-solving approach

Why Vivolta?

You will contribute to the development of products that improve and save lives. You will join an enthusiastic team of about 10 engineers that are committed to achieving a series of manufacturing for several new products. The working location will be the HQ in Waalre. As we are setting up a production facility on the High Tech Campus in Eindhoven, emphasis will shift towards most of the support on site there. You will have a big influence on manufacturing equipment, processes, and company success. You will join a professional team where collaboration, ownership, and quality are key.

We offer:

• 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 innovative
• 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 company

Questions?

Feel free to contact us at [e-mail].

Please note:

We are building our team directly and are not engaging with external recruitment agencies at this time. Also, 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.