Company Description
Pneuma Respiratory is a med-tech company based in Boone, NC, focused on inhaled drug delivery.
Position Overview
We are seeking an experienced Mechanical Engineering Consultant to review and provide expert feedback on our combination drug/device product designs. This is a consultant engagement ideal for a seasoned professional with deep expertise in medical device design and regulatory compliance for both CDER and CDRH pathways.
Primary Responsibilities
- Conduct thorough technical reviews of mechanical designs for combination drug/device products
- Assess designs for regulatory readiness under both CDER and CDRH frameworks and ISO 13485
- Evaluate drug delivery mechanisms, dosing accuracy, and device-drug interface design
- Assess design integrity, manufacturability, and compliance with industry standards
- Identify potential design flaws, risks, and areas for optimization
- Assist with validation and verification activities
- Help develop and review documentation including risk analysis, product requirements, DVV master plan, and design history files
- Collaborate with our engineering team to discuss findings and recommendations
Required Qualifications
- Bachelor's degree in Mechanical Engineering or related field (Master's preferred)
- Minimum 7-10 years of experience in medical device design and development
- Proven track record of bringing medical devices from concept through regulatory approval
- Strong knowledge of FDA regulations (21 CFR Parts 4 and 820) and ISO 13485 standards
- Experience with design controls, risk management (ISO 14971), and verification/validation processes
- Proficiency in CAD software (SolidWorks, Creo, or similar)
- Excellent analytical and problem-solving skills
- Strong written and verbal communication abilities
Preferred Qualifications
- Professional Engineering (PE) license
- Experience with inhaled drug delivery systems
- Familiarity with cross-functional drug-device development teams (formulation, regulatory, clinical)
- Experience with dose accuracy and precision testing protocols such as those provided in the CMC guidance documentation
- Familiarity with human factors engineering for self-administration devices
- Experience with design for manufacturing (DFM) and assembly automation
- Previous consulting or advisory experience
