Freelance Consultant Manufacturing Engineer Medical Device (m/w/d)
- Analysis of requirements and set up of functional specifications.
- Implementation of semi-automated systems.
- Planning, monitoring and documentation of validations.
- Management of strategic projects with interfaces to internal and external teams and customers.
- Cooperation with production for optimization projects and new process implementations.
- Support in strategy development and implementation.
- Creation and review of the technical documentation for declarations of conformity based on the Machinery Directive and risk assessment according to ISO 12100.
- Specification, qualification and monitoring of the infrastructure.
- Maintenance of machines and tools.
- Defining requirements for test/measurement and equipment.
- Development of testing / measuring and operating equipment.
- Qualifying and calibrating the testing, measuring and operating equipment.
- Creation of process and software validations.
- Technical training, technical college or university degree in engineering.
- Experience with risk management and assessment.
- 2-3 years experience in medical technology in a comparable function.
- Good knowledge of MS Office.
- Fluency in German and English (written and negotiation).
- Independent, resilient, flexible, reliable, structured and practice-oriented.
- Ability to work in a team, creativity and assertiveness.