PDPE - Project Engineer

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】

This position is for a technical role in Project Engineering Dept. in Taiwan. You will lead and be accountable for the Engineering activities related to the development of medical drug delivery systems.

【Responsibilities】

• Lead and develop a technical team of experts to support the industrialization of our autoinjectors
• Lead and manage the Subject Matter Experts (SME) from different fields related to tooling, injection molding, spring manufacturing, metal parts processing and assembly automation.
• Understand current practices and develop new or improved processes and methodologies based on in-depth processing experience.
• Promote use of new technologies and industry-leading trends. Provide the highest level of technical expertise.
• Lead Root Cause Analysis (RCA) using problem-solving methods and tools.
• Collaborate closely with plant/production manager, tool makers and maintenance, quality and process development on performance/process improvements and trouble shooting.
• Lead the development of improvement plans and requirements for capacity expansion in collaboration with our Technology Transfer team.
• Lead Design for Manufacturing & Assembly (DFMA) activities and define the manufacturing requirements for new products and product care initiatives.
• Mentor our future generation of engineers and serve as a Subject Matter Expert (SME) in engineering.

【Qualification】

• Degree in Mechanical Engineering, Polymer Science or similar education/experience.
• Minimum 2 years of relevant industry experience with hands-on experience with injection molding systems and/or automation equipment.
• Basic understanding of medical device development operations, with experience in leading technical projects e.g., cost savings initiatives or new supplier introductions.
• Statistical analysis knowledge, including an understanding of scientific molding processes, the mold- machine- material- process interactions, Design of Experiments (DoE) and mold qualification protocols
• Elementary knowledge of problem-solving and Root Cause Analysis (RCA) methodologies, six sigma certification a plus.
• Elementary knowledge in process development, verification and validation.
• Passionate & committed self-starter with an “own it” and “can do” attitude, team player and taking responsibility to get the job done.
• Able to professionally communicate with stakeholders, upper management, and external parties.
• Resilient and able to work under pressure.
• Pragmatic and data-driven mind.
• Willing the develop technical and interpersonal skills.
• Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus.
• Intercultural and interdisciplinary communication skills; able to communicate effectively in English (verbal, written) (TOEIC 750 and above).