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
* Plan, coordinate, and implement engineering changes (ECR) in collaboration with Product Leaders and stakeholders.
* Assign and track tasks to ensure timely completion.
Documentation & Compliance
* Create and maintain specifications, test documentation, work instructions, bill of materials (BOM), and material master data.
* Ensure compliance with GMP, quality standards, and regulatory requirements.
Stakeholder & Process Management
* Act as a central coordination point across engineering, production, and quality.
* Communicate progress and risks proactively.
* Train staff on updated processes and documentation.
Continuous Improvement & Projects
* Lead smaller projects (e.g., process improvements, harmonization).
* Support product development with prototyping and sample builds, material coordination, and manufacturability feedback.
Requirements
* Degree in Engineering / Automation Technology (or equivalent); State‑Certified Technician preferred.
* Experience in GMP‑regulated environments, ideally medical devices.
* Senior: 5+ years in assembly, testing, repair, and complaint handling.
* Junior/Mid: Initial experience in assembly, testing, or electronics manufacturing.
* Experience with production transfer, line design, material management, and change control (ECR/ECO).
* Strong coordination, stakeholder management, and problem‑solving skills.
* Hands‑on mindset with mechanical/electronic systems.
* Fluent German and English (mandatory).
Nice to have
* SAP knowledge.
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)
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