Process Engineer​/Mechanical Engineer​/Industrialization Engineer Medical devices

Waalre / HTC Eindhoven

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

Process Engineer

Engineering

Vivolta is a fast-growing Med Tech 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.

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.

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.

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

• 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

• 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.

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

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…