【About Company】
SHL Medical is a 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.

Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine.

【Job Overview】
As a Senior NPI Capacity Engineer in our Development Emerging Technologies department (DET), you will play an important role on successful implementation of future electrical and electro-mechanical medical device development programs.

During the design and engineering phase, your mission is to cooperate with relevant parties to plan, design, and set up the layout and process of the NPI line. You will be responsible for activities to improve the assembly flow and yield rate from a process perspective, including working with Mechanical engineers on assembly sequence improvements and assembly jig design, working with Testing engineers to improve test flow…etc

You may also cooperate and coordinate all activities with external electronics suppliers, development partners, and PCBA manufacturers.

【Main Responsibilities】
• Take ownership of the entire FATP flow and related documentation in collaboration with process developers and the quality engineering team
• Production line FATP layout and process design and setup for active medical devices including electromechanical autoinjectors, gateways, IoT add-ons, and other medical devices.
• Development of assembly processes and procedures, considering scalable manufacturing processes.
• Accountable for improvements and maintenance for manufacturing-related topics in QMS.
• Creation of production work instructions/SOPs.
• Manage station cycle time and utilization, including line balance, manufacturing efficiency, and yield improvements.
• Manage fixture, equipment, and consumable list.
• Line bring-up and production I/O control for NPI line.
• Responsible for line transfer from NPI to MP.
• Team up with quality engineers and manufacturing to analyze production testing failures and to continuously improve production yields.
• Promote lean production process, plan, and execution for continuous improvement.
• Study and propose opportunities for DFM (manufacture), DFC (cost), DFT (testing), DFA (assembly) and DFS (sustainability) improvements throughout the product development lifecycle.
• Working with production teams to optimize manufacturing processes and reduce cost through yield improvement, test time reduction, and other techniques.
• Drive and resolve engineering/production issues, including process, hardware, and test issues.
• Monitor key parameters and CQA on the production line using statistical methods and 6 sigma and DOE approaches.
• Support to monitor production yield data (yield-bridge) and deep dive into process-related issues with a systematic approach for resolution or improvement. Meanwhile, implementing continuous test enhancements to improve quality.
• Actively participate in risk assessments and the product design providing recommendations and suggestions before the project’s sample build.
• Compliance with quality standards in manufacturing workflows and processes.

【Required Skills & Qualifications】
• Degree in Engineering, Applied Sciences or similar
• 5+ years of relevant industry experience as industrial engineer, process engineer or equivalent for electromechanical devices
• Familiar with common production processes for various electronic products (ideally active medical devices)
• Established engineering capabilities in debugging production testing failures with effective engineering fixes for resolving/improving related problems.
• Good understanding of quality, reliability, and compliance requirements
• Professional written, verbal, and presentation skills in English and Chinese with the ability to effectively communicate with the stakeholders.
• Strong capability in troubleshooting with engineering team on manufacturing-related issues with various test systems
• Ability to navigate through ambiguities and concepts and realize them to practical processes or flows.
• Ability to communicate effectively and professionally across a range of technical disciplines.
• Ability to take on difficult challenges and communicate across organizational boundaries.

Preferred qualifications:
• 3+ years of experience providing technical leadership and leading projects (e.g., test, release, etc.) in a complex, matrixed organization.
• Experience in engineering and manufacturing of active medical devices
• Experienced in using SAP, creating routings, and related transactions is a plus