More jobs:
Mechanical Engineering Consultant
Job in
Boone, Watauga County, North Carolina, 28607, USA
Listed on 2026-03-08
Listing for:
Pneuma Respiratory, Inc.
Full Time
position Listed on 2026-03-08
Job specializations:
-
Engineering
Quality Engineering, Mechanical Engineer, Regulatory Compliance Specialist, Biomedical Engineer
Job Description & How to Apply Below
Pneuma Respiratory is a med-tech company based in Boone, NC, focused on inhaled drug delivery.
Position OverviewWe 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
- 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 (Solid Works, Creo, or similar)
- Excellent analytical and problem‑solving skills
- Strong written and verbal communication abilities
- 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
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