Senior / Staff Process / Manufacturing Engineer

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

Senior / Staff Process / Manufacturing Engineer

Job Category : Process Engineers

Requisition Number : SENIO001151

• Posted : October 2, 2026
• Full-Time
• On-site

Locations

Showing 1 location

Fremont, CA 94555, USA

Description

Job Summary

Serves as the technical expert for internal and external manufacturing processes, ensuring they are robust, validated, and ready to support product launch and scale-up. This role reviews concepts and supports the development and build-up of manufacturing equipment. The engineer partners with cross-functional teams and suppliers to manage risk, maintain product quality, and drive continuous process improvement.

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 required

• Excellent mechanical aptitude and good attention to details
• Strong cross-functional leadership, communication, project management, and ability to work under tight deadlines
• Excellent oral and written communication skills as well as strong interpersonal skills
• Well versed in medical device regulatory requirements from Food and Drug Administration (FDA), European
• Medicines Agency (EMA), etc. and regulatory standards

Education and experience

• 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, including supplier capability assessments and on-site audits
• Experience with risk management and problem-solving tools, including PFMEA, root cause analysis and CAPA
• Experience working in compliance with GMP and GDP regulations
• Experience in numerical modeling including CFD
• Experience in statistical analysis, including use of tools such as JMP for data analysis and experimental design
• Experience designing and troubleshooting electronic and mechanical systems
• Experience with CAD software (SolidWorks) including preparation of engineering drawings using GD&T preferred
• Experience in designing injection molded parts preferred
• Experience programming in LabVIEW a plus

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

Compensation & EEO

The base salary for this role ranges between $164,000-209,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes a discretionary bonus program, diverse health and other benefits.

Nova Pneuma, Inc. is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.