General Information
Location:
Basel, Switzerland
Type:
Freelance or temporary via Hays
Start Date:
to be discussed, ideally ASAP
Duration:
12 months with high chance of extension
Need of Service
Our client is seeking a Principal Mechanical Engineer to provide expert technical support for the development and validation of analytical methods related to combination products and medical devices, specifically autoinjectors and safety devices.
Key Responsibilities
* Conduct mechanical testing of prefilled syringes and safety devices using validated methods (e.g., break-loose force, gliding force, activation force).
* Support method validation and verification activities in compliance with internal standards and regulatory requirements.
* Document test conditions (e.g., temperature, humidity) and maintain accurate, traceable records of test results.
* Evaluate syringe-safety device assemblies through disassembly, visual inspection, and manual functional testing.
* Collaborate with cross-functional teams including Quality, Regulatory Affairs, and R&D to support product development and resolve technical issues.
* Contribute to continuous improvement initiatives in mechanical testing methodologies and laboratory practices.
Qualifications
* Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
* Hands-on experience in mechanical testing, preferably within a regulated medical device or pharmaceutical environment.
* Familiarity with force measurement systems, torque testers, and pneumatic fixtures (e.g., Zwick/Roell equipment).
* Basic understanding of GMP and ISO standards relevant to medical device testing.
* Strong attention to detail and ability to follow SOPs and test protocols precisely.
* Excellent documentation and communication skills.
* Fluent in English (written and spoken).
Preferred Skills
* Experience with statistical analysis tools (e.g., Minitab).
* Knowledge of safety device functionality and design verification processes.
* Ability to interpret mechanical test data and contribute to root cause investigations.
Scope of Work
* Mechanical testing of combination products and safety devices.
* Method validation and verification support.
* Documentation and data integrity.
* Assembly evaluation and troubleshooting.
* Cross-functional collaboration.
* Continuous improvement in lab practices.