SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.

【Job Overview】

As a Medical Software Quality Engineer, you will play a crucial role in ensuring software quality and regulatory compliance for our medical device projects developed alongside our Taiwan-based teams. You will be responsible for designing, implementing, and documenting verification plans while proactively managing software quality risks and cybersecurity compliance. This role requires expertise in software testing, a strong understanding of medical device software standards, and excellent collaboration skills to bridge cross-cultural teams effectively.

【Responsibilities】

• Provide consultation and review software design documents throughout the Software Development Life Cycle (SDLC) to ensure compliance with medical device standards.
• Develop and formalize software verification plans at the integration and system levels, covering both manual and automated verification activities.
• Record, track, verify, and collaborate with the development team on software-related issues.
• Support and review computer system validation (CSV) strategies and execute them in accordance with GAMP-5 guidelines.

【Qualification】

• Bachelor’s degree or higher in Computer Science, Engineering, or a related field.
• Minimum 3 years of experience in software/firmware development quality engineering.
• Proficiency in Python, including experience creating Python scripts; familiarity with serial ports, SciPy commands, and Wireshark is a plus.
• Strong knowledge of C programming language, with experience conducting code reviews.
• Hands-on experience with version control tools (e.g., Git) and project management tools (e.g., JIRA, Azure).
• Familiarity with Medical Device Software Product Lifecycle and GxP standards, such as IEC 62304, IEC 80002-1, IEC 81001-5-1, and GAMP-5, is preferred.
• Detail-oriented, proactive, pragmatic, and a strong team player.
• Proficiency in English (spoken and written).