Senior / Staff Process / Manufacturing Engineer - Pharma / Medical 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

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.