About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

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

Minimum 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 :

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy. 

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.
For more information on SHL Medical, please visit: shl-medical.com/careers

Please note: We do not accept applications from recruitment agencies for this position.