Senior Manufacturing Process Engineer Pharma/Med Device

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

Benefits offered by this job

Discretionary bonus

Health benefits

Job summary

Nova Pneuma, Inc. is seeking a seasoned Manufacturing Process Engineer to serve as the technical expert for internal and external manufacturing, ensuring robust, validated processes ready for product launch and scale-up.

You will lead validation strategy (IQ/OQ/PQ), drive pilot builds and capacity expansion, manage supplier performance, and mentor cross-functional teams to improve yield and quality. Familiarity with GMP/GDP and CAD tools is essential.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Industrial or Mechatronics Engineering or equivalent.
• Master’s or higher-level 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 managing suppliers through pilot builds and commercial scale-up
• Experience with risk management and problem-solving tools, including PFMEA, root cause analysis and CAPA
• GMP and GDP regulations
• Numerical modeling including CFD
• Statistical analysis, JMP
• Designing and troubleshooting electronic and mechanical systems
• SolidWorks CAD drawings with GD&T
• Injection molded parts design preferred
• LabVIEW programming a plus

Responsibilities

• Technical SME and support for internal and external manufacturing processes ensuring alignment with product requirements
• Ensure readiness for pilot builds, commercial scale-up and capacity expansion
• Drive timelines aligned to product launch milestones
• Define and ensure validation strategy for equipment (IQ/OQ/PQ) and support process performance validation
• Support or lead internal process or equipment validation efforts
• Assess internal and external technical capability
• Evaluation impact of change requests, process improvements and raw material substitution
• Perform on-site technical reviews and gap assessments
• Lead process FMEA and risk mitigation with supplier teams
• Ensure traceability from design inputs to production controls
• Draft, review and approve protocols and reports
• Analyze yield, scrap and defect data
• Review deviation investigations and CAPAs impacting product quality
• Identify process optimization opportunities
• Evaluate second-source suppliers for risk mitigation and assist with site transfers and line expansion
• Author technical justification for change controls and supplier RFC as required

Skills

Mechanical aptitude

Cross-functional leadership

Communication skills

Regulatory knowledge

Problem-solving

Project management

Attention to detail

Team collaboration

Education

Bachelors in Mechanical/ME/Industrial/Mechatronics

Masters in Engineering/Physics or related

Equivalent experience

Tools

SolidWorks

GD&T

JMP

LabVIEW

CFD

Job description

Nova Pneuma, Inc. is seeking a seasoned Manufacturing Process Engineer to serve as the technical expert for internal and external manufacturing, ensuring robust, validated processes ready for product launch and scale-up.

You will lead validation strategy (IQ/OQ/PQ), drive pilot builds and capacity expansion, manage supplier performance, and mentor cross-functional teams to improve yield and quality. Familiarity with GMP/GDP and CAD tools is essential.