Job Description
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 Engineer is responsible for ensuring the precision, accuracy, and compliance of engineering tests, feasibility studies, design assessments, and design verifications in accordance with industry standards and regulation requirements.
This pivotal role involves executing tests to verify the device function, performance, safety and compliance with customer, regulation requirement. Meanwhile seamless coordination with various departments, and leveraging advanced verification tools to uphold the validity and trustworthiness of test outputs.
Main Responsibilities
- Plan and execute test activities: Independently establish plans and schedules for engineering tests, design assessments, and verification test activities, and perform these tests to ensure device function, performance, safety, and compliance with customer and regulatory requirements.
- Root cause analysis: Perform root cause analysis for any errors that may occur from the device, testing, or equipment, utilizing engineering knowledge, statistical techniques, or risk assessment techniques to identify the root causes and risk levels.
- Data analysis and improvement suggestions: Analyze measurement data which include but not limited form engineering study, design assessment and design verification results, and provide suggestions for product performance and quality improvement to the project team.
- Laboratory safety and environment maintain: Assist in routine activities and status checks of laboratory operation, safety, access, and environmental controls. If necessary, develop and execute laboratory safety protocols, equipment qualification, calibration, and maintenance plans.
- Technical document writing and test method development: Write technical reports which include but are not limited to design assessments, design verification and deviation investigations, and develop and validate test methods, including fixture and method development, validation execution, result analysis, and reporting.
Required Skills & Qualifications
- Bachelor's degree (preferably in a STEM field) or minimum 3 years of relevant industry experience in engineering
- Experience in designing fixtures and analyzing mechanical test setups.
- Strong knowledge of mechanical validation testing and data collection.
- Ability to automate mechanical tests.
- Understanding of material failure analysis.
- Skills in statistical analysis.
- 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.
- Excellent written and verbal communication in English, TOEIC score of 700 or above (or equivalent, such as TOEFL, IELTS, or other internationally recognized certifications)
- 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
