Join a global leader in the diagnostics industry within an international Instrument Operations Network (ION) delivering innovative in-vitro diagnostic instruments.
As part of the Production Engineering - Change Services team, you will play a key role in engineering change control (ECR) and lifecycle management of diagnostic devices within a GMP-regulated environment.
You will collaborate across international teams in Switzerland, Germany, and the U.S., ensuring high-quality, compliant, and efficient implementation of product and process changes.
Key Responsibilities
Technical Change Coordination
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Plan, coordinate, and implement engineering changes (ECR) in collaboration with Product Leaders and stakeholders
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Assign and track tasks to ensure timely completion
Documentation & Compliance
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Create and maintain:
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Specifications
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Test documentation
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Work instructions
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Bill of Materials (BOM)
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Material master data
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Ensure compliance with GMP, quality standards, and regulatory requirements
Stakeholder & Process Management
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Act as a central coordination point across engineering, production, and quality
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Communicate progress and risks proactively
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Train staff on updated processes and documentation
Continuous Improvement & Projects
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Lead smaller projects (e.g., process improvements, harmonization)
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Support product development with:
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Prototyping and sample builds
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Material coordination
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Manufacturability feedback
Requirements
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Degree in Engineering / Automation Technology (or equivalent); State-Certified Technician preferred
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Experience in GMP-regulated environments, ideally medical devices
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Senior: 5+ years in assembly, testing, repair, and complaint handling
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Junior/Mid: Initial experience in assembly, testing, or electronics manufacturing
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Experience with production transfer, line design, material management, and change control (ECR/ECO)
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Strong coordination, stakeholder management, and problem-solving skills
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Hands-on mindset with mechanical/electronic systems
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Fluent German and English (mandatory)
Nice to have: SAP knowledge
Aditional information
Location: Rotkreuz, Switzerland
Start Date: June 1, 2026 (latest August 1, 2026)
Duration: 12 months (extension possible)
Workload: 100%
Hybrid: 1–3 days/month home office
Travel: 10–20% (primarily Germany)
#LI-KK1 #LI-Hybrid
