Lead Mechanical Engineer

This lead engineer works primarily with the mechanical design aspects of consumables and reagents team, representing Systems Development in reagent design - generally under the leadership of a principal engineer or functional manager. This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of mechanical engineering and any other expertise that might be held by this particular individual. This engineer is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department, and the company.

Primary Duties

Local Position Duties

• Lead R&D Activities for New Product Introduction (NPI) for the VITEK Reveal panel and sensor, supporting the full lifecycle from concept through design transfer to manufacturing.

• Own the mechanical design and development of panel and sensor process assemblies, including any plastic treatment features.

• Design, model, create drawings, and release mechanical components using CAD/PDM tools (SolidWorks) including application of GD&T (in accordance with ASME Y14.5) and tolerance analysis to ensure robust performance, and adequate interfaces with other components/instruments.

• Develop and support the validation of the plasma treatment solution including: a. Definition of plasma treatment requirements based on functional, chemical, and biological needs b. Collaboration with suppliers and process engineers on plastic treatment selection, parameters, and scalability c. Support of plastic treatment characterization, qualification, and long-term performance

• Drive DFMEA and design reviews, ensuring compliance with internal design controls and regulatory requirements and participate in PFMEA.

• Support design verification and validation (DVV) activities, including test method definition, fixture design, execution, and data analysis.

• Collaborate cross-functionally with R&D, Systems, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure design intent is met.

• Support manufacturing readiness, including DFM/DFA activities, tooling design, pilot builds, and yield improvement.

• Investigate and resolve design- or process-related issues, including root cause analysis and implementation of corrective actions.

Qualifications

Required Qualifications

• Bachelor’s degree required - Mechanical or Biomedical Engineering

• 7+ years of professional related experience in complex systems of hardware, software, biology, materials science, or chemistry

• Mechanical Engineering Post Doc experience will be considered

Preferred Qualifications

• Master’s degree or PHD Preferred - Mechanical or Biomedical Engineering

• Demonstrated understanding of design and manufacturing processes for injection molding, machining, liquid dispensing, welding, design of experiments, and capability analysis

• Strong background in mechanical design for precision consumables, preferably with medical devices, diagnostics, or life sciences instrumentation

• Experience with surface treatments and plasma coating technologies including materials compatibility and performance testing

• Previous working experience supporting product development processes from initial state including manufacturing process and transfer to manufacturing

• Experience with design verification, test development, and statistical data analysis

• Working knowledge of GMP, ISO, and FDA rules and regulatory requirements

• Hands-on mechanical and electro-mechanical troubleshooting skills of automated manufacturing equipment

• Experience in process characterization and development, acceptance testing and qualification of automated equipment

• Experience with statistical analysis software (JMP, MiniTab or similar)

• Excellent verbal and written communication skills to present summary data to cross functional team

• Project management experience would be a plus

Knowledge, Skills, and Abilities (KSAs)

(Competency category names removed as requested)

• Acting with Honor and Being Open - Consistently upholds and reflects the core ethical principles and values that company promotes.

• Communicating Effectively - Effective Presentation Skills - including the ability to present technical data.

• Dealing with Complex Situations - Demonstrates assertiveness and confidence in the face of a challenge.

• Intellectual Horsepower - Analyze data and make decisions/recommendations, using data to guide decision-making and provide suggestions for improvement.

• Intellectual Horsepower - Critical thinking, using logic and reason to analyze information and make decisions in the workplace.

• Intellectual Horsepower - Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time.

• Functionally Required Knowledge, Skills, and Abilities - Mechanical CAD for 3D Modeling and Drawings (SolidWorks preferred).

• Engineering Drawing Standards (ASME Y14 preferred).

• Theoretical mechanical engineering analysis on prospective designs.