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Director of Business Development

3 months ago

Chicago, United States ClifyX Full time

Qualifications:

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.