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 customer’s 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:
Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 60601, FDA Design Controls/QMS requirements, and EU MDR is preferred.
Roles and Responsibilities 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.