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.
Day-to-Day Duties
- 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.
Deliverables
- 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.
Qualifications
- 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.
About Korn Ferry
Korn Ferry unleashes potential in people, teams, and organizations. We work with our clients to design optimal organization structures, roles, and responsibilities. We help them hire the right people and advise them on how to reward and motivate their workforce while developing professionals as they navigate and advance their careers. To learn more, please visit Korn Ferry at www.Kornferry.com
