Lead Mechanical Engineer

Description

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:
  • Definition of plasma treatment requirements based on functional, chemical, and biological needs.
  • Collaboration with suppliers and process engineers on plastic treatment selection, parameters, and scalability.
  • 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

  • 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
  • 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
  • Previous working experience supporting product development processes from initial state including manufacturing process and transfer to manufacturing
  • Experience with surface treatments and plasma coating technologies including materials compatibility and performance testing
  • 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

  Supervisory Responsibilities

  No direct or indirect reports. Makes operational and strategic decisions with little-to-no supervisory review.