Senior Technical member for commercialized System Design Changes and refurb engineering support.
Work on part obsolescence, supplier change, raw material changes and ensure no line stops.
Prepare project plans and execute within the cost and quality goals.
Identify opportunities in cost reduction to procurement and implement cost reduction projects.
Identify and manage product risks and mitigations.
Handle the field complaints and manage escalations as per procedure (CAPA etc).
Ensure adherence to regulations quality procedures and represent the product in different audits.
Work floor layout design for utilization of space, process equipments capacity, minimum material, and people movement, in compliance with EHS regulations and facilitate import/export of required spare parts.
Experience: -
High level experience in Hardware system design (medical device only), qualification and verification.
Able to create 3D models and 2D drawings of system components in NX or similar CAD/CAM software.
Able to assess the Risk, Usability, Safety and Electromagnetic Compatibility (EMC)
of any change requirements.
Develop test protocols and perform prototype testing.
Design and produce fixtures for machining (sheet, metal, plastic etc) and assembly.
High level experience in customer complaint troubleshooting and analysis.
Positive knowledge in engineering change request management and experience with different PLM tools (Teamcenter, SAP etc).
High level experience in Product Life cycle management and awareness on FDA and EU regulations.
Cross-functional collaboration proven experience with external suppliers, Manufacturing, Sales Marketing, Service, Quality and Regulations is a must.
High level experience in Design to Cost projects.
Proven record of generating ideas for cost reduction to procurement and implementing cost reduction projects for any product line.
Experience in technical leadership of system design team and their requirements.