Senior Mechanical Engineer

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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<