Process Engineer - Electrospun MedTech Manufacturing

Vivolta; Waalre; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Pension

25+ days off

5 ADV days

Lease-a-bike option

Training opportunities

Stock Appreciation Rights (SARs)

Long-term career perspective

Job summary

Vivolta, a MedTech company in the Netherlands, is hiring a Process Engineer to scale R&D to manufacturing for electrospun medical implants. You will own equipment development from concept through manufacturing, collaborating with R&D, Manufacturing, QA and external partners in a GMP-regulated setting.

You’ll lead innovation in electrospinning equipment, validate processes, and ensure environmental and contamination controls in a growing, on-site facility at HQ in Waalre and on-site support at

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering or related field.
• 4–8 years of engineering experience in product development or manufacturing.
• Experience with 3D CAD, product testing, validation, and engineering documentation.
• Experience with process validation, equipment qualification and change control.
• Knowledge of FDA design controls, ISO 13485, and regulated product development is preferred.

Responsibilities

• Lead development, industrialization, validation, and continuous improvement of manufacturing equipment and processes.
• Industrialize electrospinning technologies and translate concepts into robust manufacturing solutions.
• Design mechanical components, assemblies, and systems for medical devices.
• Create and maintain 3D CAD models, drawings, and technical documentation.
• Collaborate with external builders, suppliers, and integrators during equipment development.
• Support cleanroom operations ensuring environmental and contamination control compliance.
• Conduct IQ/OQ/PQ and process validation activities.
• Aim to improve quality, efficiency, yield, and productivity.
• Participate in risk assessments and continuous improvement activities.
• Ensure compliance with GMP, quality, safety, and regulatory requirements.

Skills

Mechanical Engineering

3D CAD

Process Validation

GMP Knowledge

Education

Bachelor's or Master's in Mechanical Engineering

Tools

CAD Software

Job description

Vivolta, a MedTech company in the Netherlands, is hiring a Process Engineer to scale R&D to manufacturing for electrospun medical implants. You will own equipment development from concept through manufacturing, collaborating with R&D, Manufacturing, QA and external partners in a GMP-regulated setting.

You’ll lead innovation in electrospinning equipment, validate processes, and ensure environmental and contamination controls in a growing, on-site facility at HQ in Waalre and on-site support at