You will be part of LCM team for X-Ray Components Pune under CT/AMI IC R&D responsible for LCM of X-Ray Generators and Components. The (MLD) System Architect maintains and modifies X-Ray Generators for CT, Diagnostic X-Rays and other modalities, during the Life Cycle Phase of the products.
Your role:
Overall technical leadership for realization of full product life cycle management to ensure quality and compliance.
Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and supporting technical & design reviews in the frame of MLD process.
Define relevant cross functional stakeholder per change.
Manage a cross functional team.
Manage the execution of a change.
Manage stakeholders impacted by the change.
Responsible for compliance with all relevant national and international legal and intra-company regulations.
Monitoring the product quality and if necessary, initiating improvement activities.
Participates in obsolescence components management. Technical support for SICR to prevent product line down.
Responsible for post market product risk management.
Support of complaint handling by performing technical analyses and risk assessments.
You're the right fit if:
10-15 years experience with degree in M. Tech. / B.E. / B. Tech. in Electronics / Electrical Engineering.
Good knowledge of product creation and some technical competence e.g.: mechanics, electronics, software, service, industrial, procurement with a minimum of 10 years of experience.
Project management skills (planning, monitoring, escalation etc.).
able to direct and coach people for results.
have good negotiation skills with different levels in the organization.
Persistent in execution of planning and have drive for result.
knowledgeable in design for reliability practice and contribute to product quality improvement activities in operation and field.
preferably have a background in the medical device industry engineering.
knowledge of DMAIC & Statistical Engineering.