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Director Business Development MedTech Manufacturing Engineering
3 months ago
Qualifications: Remote + Travel
1. Led End-to-End NPI projects for MedTech Manufacturing Engineering projects ( >5 large programs)
2. Experience in Product launch and validation (Regulatory requirements, Manufacturing, Engineering, Lifecycle Mgt, Quality Assurance). Concept to Commercialization for >3 products; Portfolio Management
3. Experience in Business strategy, R&D and Product strategies, managed Concept to Manufacturing: feasibility, requirements, usability, systems & software engineering, integration, testing/automation, verification, reliability, security, validation, transfer to manufacturing, post launch engineering
4. Knowledge of Regulatory and Quality standards/frameworks in MedTech both Medical Devices and IVD – FDA, EU MDD, MDR/IVDR, ISO 13485, ISO 14971, ISO 62304
5. Knowledge of the end-to-end MedTech ecosystem and stakeholders.
6. Strong team building skills, strategy, and operations thinking, and solution & result orientation.
7. Ability to travel 30-40%, including global.
