Senior Process Engineer – Medical Device Scale-Up Leader

Nova Pneuma, Inc.; Fremont (CA); On-site; USD 164,000 - 209,000; Full time

Job summary

Nova Pneuma, Inc. is seeking a Senior/Staff Process/Manufacturing Engineer to act as the technical SME for manufacturing processes, ensuring readiness for pilot builds and scale-up.

The role collaborates with cross-functional teams and suppliers to manage risk, maintain product quality, and drive continuous improvement. The ideal candidate has 10+ years in medical devices with hands-on validation experience (IQ/OQ/PQ), strong CAD (SolidWorks), and proficiency in JMP/CFD tools, with GMP/GDP

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Industrial or Mechatronics Engineering or equivalent.
• Master’s or higher degree in Engineering, Physics or related field, or demonstrated equivalent experience.
• 10+ years of experience in design/development/troubleshooting of medical devices and/or electromechanical systems.
• Hands-on experience with process and equipment validation (IQ/OQ/PQ/PPQ), including authoring and approving protocols and reports.
• Experience with risk management and problem-solving tools (PFMEA, RCA, CAPA).

Responsibilities

• Serve as the technical SME for internal and external manufacturing processes.
• Ensure readiness for pilot builds, commercial scale-up and capacity expansion.
• Lead validation strategy for equipment (IQ/OQ/PQ) and process performance.
• Support or lead internal process or equipment validation efforts.
• Assess internal and external technical capability and supplier readiness.
• Lead process FMEA and risk mitigation with supplier teams.
• Ensure traceability from design inputs to production controls.
• Analyze yield, scrap and defect data; review CAPAs.

Skills

Excellent mechanical aptitude

Cross-functional leadership

Project management

Regulatory knowledge (FDA/EMA, GMP/GDP

Strong communication

Root cause analysis / problem solving

Education

Bachelor’s degree in Mechanical, Electrical, Industrial or Mechatronics Engineering or equivalent

Master’s or higher degree in Engineering, Physics or related field

10+ years of experience in medical devices design/development/troubleshooting

Tools

SolidWorks

LabVIEW

JMP

CFD modeling

Job description

Nova Pneuma, Inc. is seeking a Senior/Staff Process/Manufacturing Engineer to act as the technical SME for manufacturing processes, ensuring readiness for pilot builds and scale-up.

The role collaborates with cross-functional teams and suppliers to manage risk, maintain product quality, and drive continuous improvement. The ideal candidate has 10+ years in medical devices with hands-on validation experience (IQ/OQ/PQ), strong CAD (SolidWorks), and proficiency in JMP/CFD tools, with GMP/GDP