- A seasoned medical devices practitioner with 15 years relevant experience in medical devices sustenance engineering and Life Cycle management. Valuable exposure to responding to large sustenance engineering proposals.
- Job DescriptionThe Ideal Candidate
More than an engineering delivery leader with 15+ Years of relevant experience in Medical Devices & Healthcare and life sciences domain across modalities. Should be MedTech Product Lifecycle Management expert who understands how to keep medical products compliant, manufacturable, supportable, secure, competitive, and economically viable throughout their lifecycle.
Candidate can diagnose a customers lifecycle challenges, define the right operating model, mobilize a large engineering organization, and remain accountable for the product and business outcomes.
Experience in several of the following areas is highly desirable:
Sustaining Engineering | Product Modernization | Obsolescence Management | Component Lifecycle Management | ECO/ECN | Configuration Management | Design Transfer | Product Industrialization | Cost Reduction | Value Engineering | Regulatory Maintenance | CAPA | Risk Management | V&V; | Cybersecurity Lifecycle Management | Software Lifecycle Management | End-of-Life Management | PLM / Digital Engineering
Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 60601, FDA Design Controls/QMS requirements, and EU MDR is preferred.