Mechanical Engineering Consultant
Job in
Boone, Watauga County, North Carolina, 28607, USA
Listed on 2026-07-08
Listing for:
Ports North
Full Time
position Listed on 2026-07-08
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist, Mechanical Engineer
Job Description & How to Apply Below
Overview
We are seeking an experienced Mechanical Engineering Consultant to provide expert review and guidance on the development of combination drug/device products. This individual will evaluate mechanical designs, assess regulatory readiness, identify technical risks, and recommend design improvements to support successful product development and commercialization.
Key Responsibilities- Review and assess mechanical designs for combination drug/device products.
- Evaluate drug delivery mechanisms, dosing accuracy, and device-drug interfaces.
- Assess design integrity, manufacturability, reliability, and compliance with industry standards.
- Ensure designs align with CDER, CDRH, and ISO 13485 requirements.
- Identify design risks, gaps, and opportunities for optimization.
- Support verification and validation planning and execution.
- Review technical documentation, including product requirements, risk analyses, DV&V plans, and Design History Files (DHF).
- Collaborate with engineering, quality, and regulatory teams to discuss findings and recommendations.
- Review CAD drawings, specifications, and design documentation.
- Participate in design review meetings and provide technical feedback.
- Evaluate product risks and recommend mitigation strategies.
- Review verification and validation protocols and results.
- Assess compliance with regulatory and quality requirements.
- Document findings, recommendations, and action items.
- Support engineering teams in resolving design challenges.
- Design review reports and technical assessments.
- Risk identification and mitigation recommendations.
- Regulatory readiness and compliance evaluations.
- Design optimization recommendations.
- Reviews of DV&V plans, risk analyses, and DHF documentation.
- Written summaries of findings, gaps, and corrective actions.
- Stakeholder presentations and design review feedback.
- Bachelor's degree in Mechanical Engineering or related field.
- 10+ years of experience in medical device and/or combination product development.
- Expertise with CDER, CDRH, ISO 13485, design controls, and risk management.
- Experience with drug delivery systems and verification/validation activities.
- Strong communication, documentation, and cross-functional collaboration skills.
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