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.
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γJob Overviewγ
You will be responsible for ensuring software quality by creating, reviewing, and executing verification and validation plans for the electromechanical autoinjector product and its manufacturing test fixtures.
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γResponsibilitiesγ
- Create, review, and execute software validation activities (Performance Qualification) for the manufacturing test fixture.
- Evaluate the software design of the manufacturing test fixture through optimal means (Design Qualification).
- Involve in the Software Development Life Cycle (SDLC) process and review the software design deliverables.
- Create and execute manual and automated software verification activities of the electromechanical autoinjector product.
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γQualificationγ
- Bachelor's degree or higher in Computer Science or Engineering.
- Minimum of 2 years of experience in a Software/Firmware Development Quality Engineering role.
- Proficiency in Python, with experience in creating Python scripts.
- Experience using Python to work with serial ports, SciPy commands, and Wireshark is a plus.
- Experience working with DBMS (MySQL, PostgreSQL, SQLite, etc.) and the verification of it is a plus.
- Proficiency in code version control tools (e.g., Git) and project management tools (e.g., JIRA, Azure).
- Knowledge of applicable Medical Device Software Product Lifecycle and GxP standards (IEC 62304, IEC 80002-1, GAMP-5) is preferred.
- Result-oriented, team player, pragmatic, and proactive.
- Proficient in English (speaking, reading, and writing).