Taking care of activities in the field of development, optimization and implementation of new and existing production (sub) processes and methods. Designing, manufacturing and installing the necessary equipment and software to achieve a reliable, robust and efficient production process on the basis of continuous improvement.
Process engineers : developing technology and processes for high-quality production
Automation engineers : developing automated and / or robotized processes
Manufacturing engineers : optimizing and improving production processes
Utility engineers : developing and improving utilities for high-quality production
- Deliver on operation plan goals for Surgical , with focus on harmonization of manufacturing processes, procedures, technology and methods as an enabler for seamless NPI launches and future dual site launch capabilities. This roll will lead the IOL platform harmonization program across the 2 sites.
- Develop new production processes and (test) methods, scale them up and optimize them.
- Designing, manufacturing and installing the necessary equipment
- Development / adaptation of raw materials and / or the specifications for this
- Development of production materials
- Design, development and realization of (concept) ophthalmic Medical
Devices using the Design Control process in New Product Introduction projects.
- Performing Product or Process Transfers to and from other locations.
- Participate in or lead project teams and other consultative bodies with regard to their own task area
- Preparation of protocols, reports and execution of validation tests
- Drafting and documenting process specifications and work and operating instructions
- Increasing and transferring process knowledge through training and instructions
- Technically oriented training at a minimum HBO level, preferably mechanical engineering, chemistry, automation or electrical engineering
- Several years of relevant work experience, preferably in the pharmaceutical or medical device industry.
- Seniority in the position mainly depends on the complexity and / or size of projects and activities, and the degree of independence in the implementation.
- Relevant GMP, QSR, MDD / EU MDR, ISO 13485, ISO 14971, ISO 11979
- Knowledge of relevant work instructions and procedures
- Knowledge of Lean Six Sigma
- Design Control
- Product and process validations
- Design For Manufacturability (DFM)
- Automation, Robotica, Industry 4.0
- Metrology en/of Sensoring
- Flexible and accurate
- Able to function independently as well as in a team.
- Continuous Improvement / Innovation oriented
- Excellent command of the Dutch and English language