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As part of the LD Consumables Systems Engineering team, the Senior System Engineer will be responsible for the design, integration, and validation of automated medical diagnostic consumable device manufacturing equipment, batch processing systems, and semi-finished reagent formulation systems.

Apply mechanical and/or electrical process automation principles and technology to design, develop, document, install, qualify, and optimize new and upgrade existing automated medical diagnostic consumable device manufacturing equipment, batch processing systems, and semi-finished reagent formulation systems in a constantly changing fast-paced environment. 

Work closely with cross-functional design team members to ensure that the full understanding of subsystem/system functionality and performance is developed. 

Identify solutions to complex technical issues by troubleshooting, determining root cause, and then proposing design modifications as they pertain to highly complex automated production assembly and packaging system performance. 

Establishing business case, driving capital approval, and managing small to medium size projects for business expansion, quality improvements or efficiency improvements to existing equipment.   

Analyze system performance test data and establish acceptance criteria. 

Anticipate potential problems that may impact system performance and develop risk mitigation plans. 

Apply technical writing skills by creating technical documentation such as validation documentation, functional specifications, user requirements, and manufacturing work instructions. 

Assure compliance to all design characterization, integration and verification quality procedures and policies of process development and validation. 

Collaborate with Technical Operations, Finance, and Manufacturing teams. 

Providing routine off-hour process support for mechanical equipment issues, typically one week in every 10 to 12 weeks, or as required. 

 

Knowledge/Skills, Education, and Experience: 

Demonstrated systems and design engineering experience in complex electromechanical instrumentation in both a new process development environment as well as supporting existing installed equipment. 

Experience with mechanical CAD design and documentation systems, preferrable NX or SolidWorks, and a knowledge of detailed part design, tolerancing and assembly to approve mechanical designs.  

 

Working knowledge and application experience with Lean business systems and methodologies such as TPM, 5S, Lean 3P Design, & OEE Monitoring.   

Working knowledge of Change Control and Change management, including process equipment Commissioning and Validation (FAT, IQ, OQ, PQ) is preferred. 

Demonstrated ability to lead and collaborate with technical teams and drive results. 

Experience working with large cross organizational multidisciplinary teams. 

Bachelor’s degree in Mechanical/Electrical/Chemical Engineering or related discipline. 

5-8 years supporting and installing manufacturing automation and process control designs; including experience in a cGMP Manufacturing environment. 

Willingness to travel up to 10% 

 

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

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