Senior Support Lead

Experience: 2 to Not Available years

Location: Hyderabad, India

Skills: mechanical design, electrical design, medical products development, sustaining regulated devices, Design Control, 21 CFR 820, ISO13485, ISO14791, MDR, technical documentation, root cause analysis, collaboration, pro-active working attitude

Job Summary
To execute continuous improvement activities, work on root cause analysis, and provide technical assistance to resolve customer issues.

Profile
R&D; Sustaining Engineer OEM nonLM (w/m/d)

Tasks:
• Provide support to products post launch, coordinating design and manufacturing changes and improvements to meet defined specifications (esp. device and manufacturing requirements) as part of life cycle management (changes, QIS, CAPA etc.) in cooperation with other specialist departments, taking into account medical application requirements and economic requirements. This applies to product supply types off the shelf/ Goods for Resale, Olympus is not legal manufacturer).
• The particular focus is on identification and fulfilling and assure distributor/ importer requirements from the Medical device regulation (EU Medical Device Regulation MDR (2017/745)
• Maintain a strong and current process understanding of new product implementation (SOP 7.3 _030 Collaborative PDD) and changes according to GOP_01.01 (Change Management) of medical device design to meet or exceed customer, company and project need.
• Generate, modify and review technical documentation for non LM products (EOICL, ASP, …) in compliance with R&D; CE Specification Guidance, Medical device regulations, company developed standards throughout the product life cycle to ensure the design is fully documented.
• Preparation,



tracking and reporting of deliverables with internal and external stakeholders including supplier communication in cooperation with purchasing department and project manager.
• Track and maintain change activities of defined change working packages via Olympus specific PLM system.
• Evaluation of necessary compatibility requirements and evidences. If needed, coordination or performance of tests according to applicable system chart.

Qualification:
• Bachelor’s or Master’s degree in Engineering or equivalent professional education (any other medical technology background)
• Generic understanding of mechanical and electrical design
• 2+ years of skilled experience
• Knowledge of the process-orientated development of medical products is desirable
• Knowledge in sustaining regulated devices under Design Control (21 CFR 820), ISO13485, ISO14791, MDR desirable.
• fluently spoken English skills
• Structured way or working
• Robust collaboration and communication skills
• Independent and pro-active working attitude

Key Responsibilities
1. To act as a point of escalation for complex and high-priority customer issues, ensuring timely resolution.
2. To create the root cause analysis for critical issues and put in place necessary preventive measures to reduce future defects.
3. To collaborate closely with product management, development, and QA teams to provide feedback on product improvements, influence product design, and ensure alignment with customer needs.
4. To provide technical assistance to the team members in resolving customer issues.
5. To drive continuous improvement initiatives for support processes, workflows and Identify opportunities for innovation, automation, and efficiency enhancements.

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