Company Overview
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the Unites States.
Job Overview
The Verification Senior Engineer is responsible for ensuring the accuracy, precision, and compliance of engineering tests, feasibility studies, design assessment and verification activities. They are responsible for using advanced verification tools to ensure the validity and reliability of test results, confirming that device functionality, performance, and safety meet both industry standards and regulatory or customer requirements.
This pivotal role requires strong technical expertise, along with effective communication skills to support cross-functional collaboration and seamless coordination across teams. Additionally, the senior engineer is expected to mentor and support junior team members, helping them build both technical proficiency and professional capabilities under proper supervision.
Main Responsibilities
- Independent Work and Efficiency : Work independently with high efficiency and be capable of further planning, coaching, and continuous improvement. Create and assist in the implementation of the Operations Skills Training Program and regularly report on the execution performance to management.
- Multiple tasks management : Manage multiple tasks simultaneously while efficiently allocating time and resources, and communicate directly with technical teams and project managers to meet their requirements appropriately by analyzing and understanding demands.
- Root Cause Analysis: Perform and coach others in conducting root cause analysis for errors using engineering knowledge, statistical technology, or risk assessment techniques to identify potential failure factors and provide recommendations for corrective actions.
- Product Performance Prediction: Utilize engineering knowledge, simulation tools, AI engineering, and other methods to predict product performance and problem trends. Provide improvement recommendations for design changes to enhance product performance and quality.
- Data Analysis for Product Improvement: Perform data analysis, including verification and measurement data, and provide design suggestions for product performance and quality improvement based on the analysis results.
- Test Method Development and Validation: Independently perform and/or coach others in conducting test method development and validation activities, which include fixture and method development, validation execution and analysis, and creation of documents that include method D&V plans, protocols, reports, and test instructions.
Required Skills & Qualifications
- Bachelor's degree (preferably in a STEM field) or minimum 5 years of relevant industry experience in engineering
- Excellent written and verbal communication in English. (TOEIC score of 750 or above or equivalent, such as TOEFL, IELTS, or other internationally recognized certifications)
- Experience in designing fixtures and analyzing mechanical test setups.
- Strong knowledge of mechanical validation testing.
- Ability to automate mechanical tests.
- Understanding of material failure analysis.
- Skills in statistical analysis.
- Knowledge or practice of Product Risk Management
- Familiarity with industrial manufacturing processes.
- Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Documentation Practices (GDP).
Desirable (nice to have)
- Hands-on experience in designing and testing mechanical products.
- Proficiency in using mechanical engineering tools for test method development.
- Strong problem-solving and analytical skills.
- Good interpersonal skills and a team-oriented mindset..
We Offer
- An exciting opportunity in a fast-growing international medical device company
- A modern working environment, with multicultural and dynamic teams
- Flexible working hours and a hybrid remote work policy
