Assembly Automation Process Engineer I

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

The Assembly Process Development Department (PDAP) in Taiwan plays a crucial role in designing, developing, and implementing assembly automation that aligns with SHL's overall corporate strategy. The Senior Automation Engineer position is integral to this mission, requiring a dedicated and experienced professional with a strong technical background and meticulous attention to detail. This role also demands significant experience in automation technologies and project management.

Key responsibilities include leading projects focused on the implementation of automated machines for assembly, packaging, and other fully automated process across SHL's manufacturing plants worldwide.

Main Responsibilities

1. Project Management:

• Responsible for the industrialization of fully automated assembly equipment for auto-injector, or assembly lines of semi-automatic assembly equipment
• Lead and manage automation projects from concept through to implementation, ensuring alignment with project timelines and budget.
• Develop detailed project plans, including resource allocation, milestones, and risk management strategies.
• Coordinate with cross-functional teams to ensure smooth project execution.

2. Technical Leadership:

• Oversee the design and development of automated assembly equipment for auto-injectors. • Provide technical expertise and guidance to both internal teams and external automation integration partners.
• Ensure that all automated systems meet stringent quality and regulatory standards.

3. Process :

• Work closely with automation integration companies to specify requirements, review designs, and validate performance.
• Specify, Review design, verify and test equipment, and transfer automation equipment to Manufacturing that meets or exceed expectations in terms of lead-time, compliance, quality, performance, yield, availability and output.
• Collaborate with internal quality and validation teams to ensure that all processes comply with quality standards and regulatory requirements.
• Facilitate effective communication between internal departments and external partners to resolve technical issues and optimize system performance.
• Collaborate with the Validation team and conduct equipment qualification and validation.
• Work together with Suppliers, the Manufacturing Department and the Validation Department to maintain and improve general specifications (e.g. table height, allowed materials) and workflows (e.g. Validations Department shall approve materials before Supplier starts building equipment, ensure that the equipment can operate for 8 hours before it leaves Supplier)
• Support and provide historical data to the Process Team to identify what assembly steps needs to be de-risked/tested in the lab.
• Translate the process defined by the Process Team into requirement specifications for Suppliers (e.g. stop on force/distance, center part on dimension X)
• Translate risk analysis into requirement specifications (e.g. component might break – supplier shall have a camera inspection)

4. Process Optimization:

• Identify opportunities for process improvements and implement best practices in automation.
• Conduct thorough testing and validation of automated systems to ensure optimal performance and reliability.
• Monitor system performance post-implementation and make necessary adjustments to enhance efficiency.
• Do root cause investigation for technical issues

5. Documentation and Compliance:

• Maintain comprehensive documentation for all phases of the project, including design specifications, testing protocols, and validation reports. Responsibility include but not limited to: user requirement, engineering report, factor and site inspection protocol and reports, work instruction, time lines and project status updates,etc…
• Ensure that all project activities comply with company policies, industry standards, and regulatory requirements.
• Prepare and present regular project updates to senior management and other stakeholders. 6. Training and Support:
• Provide training and support to manufacturing and maintenance teams on new automated systems.
• Develop training materials and standard operating procedures (SOPs) for automated equipment.
• Offer ongoing technical support to resolve any issues that arise during production.
• Transfer knowledge to the Manufacturing Department

Required Skills & Qualifications

1. Educational Background:

• Bachelor’s degree in Engineering, preferably in Industrial, Mechanical, Electrical, Automation, or a related field. A Master’s degree or higher is a plus.

2. Experience:

• Minimum of 4-8 years of experience in process automation, specifically within the medical device industry, automative or a similarly regulated field.

3. Technical Skills:

• Extensive knowledge of automation technologies, robotics, and control systems is a plus.
• Proficiency in using CAD software and other engineering design tools.
• Familiarity with PLC programming, HMI development, and SCADA systems is advantageous.
• Strong understanding of manufacturing processes and industrial automation integration.

4. Project Management:

• Certification in project management (e.g., PMP) is highly desirable.
• Demonstrated ability to manage projects from inception to completion, including planning, resource allocation, risk management, and budget control.

5. Regulatory and Quality Standards:

• Thorough understanding of regulatory requirements and quality standards pertinent to the medical device industry, such as ISO 13485, FDA regulations, and GMP is a plus.
• Experience with validation and qualification processes for automated equipment is advantageous.
• Flexibility and adaptability to work in a fast-paced and dynamic environment.

6. Other Qualifications:

• Willingness to travel to different global manufacturing sites or foreign suppliers in Europe as required for 2 to 8 weeks a year depending on projects assigned.
• Proficiency in English; additional language skills are advantageous.

We offer

• Competitive compensation package.
• Modern & variety of culture working environment with state-of-the-art facilities and technologies.
• Challenging assignments in a fast growing and innovative industry.
• Position in a dynamic, international team of highly skilled professionals.
• Various opportunities for personal and professional development within a global organization.