Production Engineer

About

The Instrument Operation Network (ION) from Roche delivers reliable and innovative instruments for in-vitro diagnostics to our subsidiaries and customers. We manufacture a wide range of instruments, from point-of-care devices to large routine laboratory equipment. Our network has four hubs, meaning we work from 4 locations (Mannheim, Ludwigsburg, Tucson, Rotkreuz). As a network, we collaborate to continuously improve manufacturing costs, strive for timely delivery of the best quality instruments, and enable Roche to bring innovative and differentiated instruments to market. With multiple locations and specializations, our network employees have many paths to explore the world of diagnostics in their best interest.

Our Production Engineering Chapter comprises over 100 talented engineers and technicians across four different locations in Europe and the USA. As a Service Department, our primary focus is on proactively designing, optimizing, and maintaining production processes and product designs for the ION Network. We are committed to staying at the forefront of technology and industry trends, leveraging our expertise to achieve operational excellence.

The global Production Engineering - Change Services Sub-Chapter is part of the global Engineering Chapter and is responsible for cost-effective, reliable, and lean Change Control Management (ECR). This team's scope primarily involves product maintenance for established products and the introduction of new products from the pilot phase to commercial production. The Sub-Chapter contributes technical expertise to successfully implement material, system, process, and product changes.

The perfect candidate is a goal-oriented, senior team player with a high standard of quality. He/she possesses a completed technical education (FH/state-certified technician) in technology and automation engineering. Experience in project transfer to production, design of production lines, material management, and coordination, setup, and repair of breadboards/functional models of complex mechatronic systems in a GMP environment (preferably regulated medical devices) is required. Proven experience in complex process coordination, change and stakeholder management with a service and 'we can do it' mentality for active structural improvement is assumed. Strong team and communication skills, as well as very good German and English skills, are essential for international collaboration in the matrix organization (ION Network: DE, CH, USA).

Responsibilities

• Coordinate technical changes: Responsible for planning, coordinating, technically evaluating, assigning tasks, and implementing changes in consultation with the Product Leader and/or Sub-Chapter Lead.
• Create and maintain specification and test documents, work plans, master data, and bills of materials. Train on required documents and responsible for smooth incoming and outgoing control of changes in production.
• Proactively control and communicate for the timely completion of ECRs.
• Responsible for meeting quality targets, deadlines, and regulatory requirements, such as responsibility for test documents and master data for product manufacturing.
• Manage smaller projects assigned by the Product Lead or Sub-Chapter Lead (e.g., continuous improvement process, harmonization projects).
• Support development projects and assist, e.g., in creating samples and prototypes, coordinate required materials, and provide feedback on manufacturability.

Qualifications

• Completed technical training with a Fachhochschulreife, and further training as a state-certified technician in technology and automation engineering.
• 1st position: minimum 5 years of professional experience in assembly, testing, complaint processing, and repair of medical diagnostic devices. Practical experience in device assembly and/or as a skilled worker in electronics or as a technical expert is advantageous.
• 2nd-4th position: initial experience in assembly, testing, complaint processing, and repair of medical diagnostic devices. Practical experience in device assembly and/or as a skilled worker in electronics or as a technical expert is advantageous.
• Experience in transferring new projects into production, as well as in designing production lines, 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.
• Proven experience in coordinating complex processes, change and stakeholder management with a strong service mentality and a 'we can do it' mentality to actively break down existing structures.
• Strong team and communication skills for successful work in an international matrix organization. Due to the ION Network interfaces in Germany, Switzerland, and the USA, very good German and English skills, both written and spoken, are required. These enable international collaboration.
• Willingness and corresponding affinity to learn new digital tools and enjoyment of working in a changing environment with corresponding flexibility and personal responsibility.
• Willingness for occasional assignments in neighboring countries.

Nice to haves

• SAP knowledge

Reference No.: 924888 Role: Production Engineer Industry: Pharma Work Location: Rotkreuz Scope: 100 % Start: (Latest possible start date: ) Duration: 12++ Application Deadline:

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About Us

ITech Consult is an ISO 9001:2015 certified company with branches in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary employment in the fields of IT, Life Science & Engineering.

We offer temporary employment & payroll services. This is free for our candidates, and we do not charge you any additional fees for payroll services. jidda5fdd2x jit0416x jiy26x