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Freelance Consultant Manufacturing Engineer Medical Device (m/w/d) (EN)
[12038]
Manufacturing
Job title: Freelance Consultant Manufacturing Engineer Medical Device (m/w/d) Industry: Dienstleister MedTech Skills: Manufacturing Start of project: ASAP Duration of the project : 9 Months Location: Zürich, Schweiz Tasks: ·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.
Skills: Manufacturing
- 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.
Leïla Fehr