Process Engineer – Electrospinning Manufacturing

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

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