PDPE - (Senior) Project Engineer

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems for the past 30 years 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 with sites in Sweden, Taiwan, and the Unites States.

【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.

【Main 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.

【Skills and 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 800 and above).