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.

Qualifications

• 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.