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

Pneuma Respiratory, Inc.

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