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Production engineer (ivd & medical devices)

Risch
Randstad Switzerland
Inserat online seit: Veröffentlicht vor 12 Std.
Beschreibung

PpFor one of our clients, a world leader in in-vitro diagnostics, we are currently looking for a bProduction Engineer. /b /p h3General Information: /h3 ul liLatest Start Date: /li liPlanned duration: 1 year with the possibility of extension /li liHome Office: possible, 1-3x in a month /li liTeam: 70 People across all locations /li liDepartment: Sub-Chapter Change Services Core Lab PoC 1 (DODRCE) /li liWorking hours: Standard /li /ul h3About the job: /h3 pOur client manufactures a wide range of instruments, from point-of-care devices to large routine laboratory equipment. Their network operates across four hubs or locations: Mannheim, Ludwigsburg, Tucson, and Rotkreuz. They collaborate to continuously improve manufacturing costs, strive for the timely delivery of highest-quality instruments, and thereby enable them to bring innovative and differentiated instruments to the market. With multiple locations and areas of expertise, our network offers employees many paths to explore the world of diagnostics in their best interest. /p pTheir Production Engineering Chapter comprises over 100 talented engineers and technicians across four different locations in Europe and the USA. As a service department, their primary focus is on proactively designing, optimizing, and maintaining production processes and product designs for the ION Network. /p pThe global Sub-Chapter Production Engineering - Change Services is part of the global Engineering Chapter and is responsible for cost-effective, reliable, and lean Change Control Management (ECR). This team's scope of work primarily covers product maintenance topics for established products and the introduction of new products from the pilot phase through to commercial production. The sub-chapter provides technical expertise to successfully execute material, system, process, and product changes. /p h3The Perfect Candidate: /h3 pGoal-oriented, senior team player with high quality standards. He/she holds a completed technical degree/qualification (University of Applied Sciences / state-certified technician) in engineering and automation technology. Required experience includes project transfer into production, production line design, material management, as well as the coordination, assembly, and repair of breadboards/functional models of complex mechatronic systems within a GMP environment (preferably regulated medical devices). Proven experience in complex process coordination, change management, and stakeholder management—paired with a service-oriented and "can-do" mentality to actively improve structures is required. Strong teamwork and communication skills, as well as excellent written and spoken German and English, are essential for international collaboration within the matrix organization (ION Network: DE, CH, USA). /p h3Tasks responsibilities: /h3 ul liCoordination of Technical Changes: Responsibility for planning, coordination, technical evaluation, task assignment, and implementation of changes in consultation with the Product Leader and/or Sub-Chapter Lead. /li liCreation and maintenance of specification and testing documentation, work plans, material master data, and bills of materials (BOMs). Training on required documentation and responsibility for the smooth incoming and outgoing control of changes in production. /li liProactive monitoring and communication to ensure the timely completion of ECRs. /li liResponsibility for compliance with quality targets, deadlines, and regulatory requirements, such as oversight of testing documents and master data for product manufacturing. /li liManagement of smaller projects assigned by the Product Lead or Sub-Chapter Lead (e.g., continuous improvement processes, harmonization projects). /li liAccompanying development projects and providing support, for example, in the creation of samples and prototypes, coordinating required materials, and providing feedback on manufacturability. /li /ul h3Must Haves: /h3 ul liCompleted technical education/degree with a higher education entrance qualification (Fachhochschulreife), as well as further training as a state-certified technician in the field of engineering and automation technology. /li libFor Position 1: At least 5 years of professional experience in assembly, testing, complaint handling, and repair processing of medical diagnostic equipment. Practical experience in instrument assembly and/or as a skilled electronics worker or technical expert is an advantage. /b /li libFor Positions 2–4: Initial experience in assembly, testing, complaint handling, and repair processing of medical diagnostic equipment. Practical experience in instrument assembly and/or as a skilled electronics worker or technical expert is an advantage. /b /li libExperience transferring new projects into production, as well as in production line design, material management, and the coordination, setup, and repair of breadboards and functional models of complex mechatronic systems in a GMP environment, preferably for regulated medical devices. /b /li liProven experience coordinating complex processes, change management, and stakeholder management with a strong service mentality and "can-do" attitude to actively challenge and improve existing structures. /li liStrong teamwork and communication skills to work successfully within an international matrix organization. Due to the ION Network interfaces in Germany, Switzerland, and the USA, you stand out with bexcellent written and spoken German and English skills. /b These will enable your international collaboration. /li liWillingness and affinity to learn new digital tools, and enjoyment in working within a changing environment with the corresponding flexibility and self-reliance. /li liWillingness to occasionally travel for deployments in neighboring countries. /li /ul h3Nice to haves: /h3 ul liKnowledge of SAP /li /ul h3Application Submission Deadline: /h3 /p #J-18808-Ljbffr

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