Senior Mechanical Engineer - Medical Diagnostics R&D Lead

Planet Pharma; Hazelwood (MO); On-site; USD 120,000 - 170,000; Full time

Job summary

Planet Pharma seeks a lead mechanical engineer to drive the design and development of the VITEK Reveal panel and sensor, from concept through transfer to manufacturing. You will own mechanical assemblies, apply GD&T, and oversee plasma treatment validation while coordinating with R&D, Manufacturing, and Regulatory teams.

Ideal candidates have 7+ years in complex hardware systems, experience with design reviews and DFMEA, and a strong background in precision consumables or medical devices.

Qualifications

• Bachelor’s degree required in mechanical or biomedical engineering.
• 7+ years of professional experience in complex hardware/software/biological systems.
• Experience with injection molding, machining, surface treatments and plasma coating is a plus.

Responsibilities

• Lead R&D activities for NPI for the VITEK Reveal panel and sensor from concept through design transfer to manufacturing.
• Own mechanical design and development of panel and sensor process assemblies, including plastic treatment features.
• Design, model, create drawings, and release mechanical components using CAD/PDM tools (SolidWorks) with GD&T per ASME Y14.5.
• Develop and support validation of plasma treatment solutions including requirements, supplier collaboration, and characterization.
• Drive DFMEA and design reviews; participate in PFMEA and ensure design controls and regulatory compliance.
• Support DVV activities: test method definition, fixture design, execution, and data analysis.
• Collaborate cross-functionally with R&D, Systems, Manufacturing, Quality, Regulatory, and Supply Chain.
• Support manufacturing readiness: DFM/DFA, tooling design, pilot builds, yield improvement.
• Investigate and resolve design/process issues with root cause analysis and corrective actions.

Skills

Mechanical design

SolidWorks

GD&T

DFMEA

PFMEA

DVV

GMP/ISO/FDA knowledge

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Master’s degree or PhD in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

Planet Pharma seeks a lead mechanical engineer to drive the design and development of the VITEK Reveal panel and sensor, from concept through transfer to manufacturing. You will own mechanical assemblies, apply GD&T, and oversee plasma treatment validation while coordinating with R&D, Manufacturing, and Regulatory teams.

Ideal candidates have 7+ years in complex hardware systems, experience with design reviews and DFMEA, and a strong background in precision consumables or medical devices.