Test Engineer for unit testing HS/SW

Elan AG seeks a Senior Test Engineer in Rotkreuz to lead hardware unit testing for Blood Gas & Electrolytes Analyzers, ensuring regulatory compliance and product reliability through automated and physical validation.

This position sits within a cross-functional engineering group dedicated to verifying hardware units and subsystems. The engineer will play a key part in developing the next generation of Blood Gas & Electrolytes Analyzers, ensuring they meet high standards for quality, robustness, and reliability before system-level integration. The role is based in Rotkreuz, Switzerland, with some flexibility in how responsibilities are tailored.

Responsibilities

• Create, prepare, and run automated test suites, cases, and protocols for Verification and Validation (V&V) in line with medical device regulations.
• Perform accelerated life testing (ALT), durability checks, and wear-and-tear assessments to guarantee long-term performance.
• Construct custom test setups, fluidic rigs, and fixtures using CAD tools, integrating sensors, pumps, and actuators.
• Write Python automation scripts to control test rigs, collect data, and analyze complex metrics using statistical methods.
• Conduct root cause analysis for defects, offer design feedback for manufacturability, and collaborate with software, firmware, and systems teams.
• Evaluate electro-mechanical hardware and configure lab instruments such as encoders and oscilloscopes.
• Execute tightness, stress, and endurance tests on fluidic consumables.
• Perform physical testing on precision hardware, evaluate microfluidic chips, and handle biological samples in a BSL-2 laboratory.
• Manage Unit Specifications, Configuration & Item Management, tracking CIs and revision statuses.

Requirements

• A degree in Mechanical Engineering, Electrical Engineering, Mechatronics, Biomedical Engineering, or a related field (BSc, MSc, PhD, or equivalent HF Apprenticeship).
• 3 to 10+ years of hands-on experience in hardware testing, mechatronic unit verification, or product development.
• Proven expertise in highly regulated medical device, In Vitro Diagnostics (IVD), or life sciences environments (FDA/MDR).
• Strong experience with Application Lifecycle Management (ALM) systems (e.g., Codebeamer or PLM) for requirement traceability.
• Professional proficiency in English is mandatory.

Nice to have

• Fluency or strong understanding of German is a distinct advantage or required for daily operations, depending on the focus.
• Proficiency in agile tools like Jira.

What the company offers

• Opportunity to work in one of the world's most important pharmaceutical companies.
• Access to a modern campus with plenty of green spaces and meeting areas.
• Central location in Rotkreuz not far from the train station.
• Further training opportunities through temptraining.

About the company

Elan AG is recognized as one of the world's most important pharmaceutical companies. The work environment is described as collaborative and high-impact, offering employees the chance to contribute significantly to critical medical technology advancements.

• Collaborative work environment.
• High-impact contributions to medical technology.
• Modern campus with green spaces.

How to apply

Application language: English