Senior System Designer

3 days ago

Thiruvananthapuram, Kerala, India beBeeDesign Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title:

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Systems Design Engineer

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About the Role

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  • We are seeking a skilled Systems Design Engineer to translate user needs and business requirements into specifications that drive the design, implementation, and testing of products used for blood collection and blood components.">
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Key Responsibilities

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  • Translate user and business requirements into detailed product requirement specifications and design specifications.">
  • Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development.">
  • Lead multidisciplinary design efforts to ensure seamless integration and timely delivery.">
  • Collaborate globally to integrate mechanical, electrical, and software components, achieving functional and reliability goals.">
  • Lead design changes to implement and enhance features for blood collection platforms, ensuring quality and regulatory compliance.">
  • Independently conduct technical reviews with stakeholders to meet project design objectives.">
  • Perform failure analyses to prioritize testing and ensure design completeness and product quality.">
  • Communicate and collaborate effectively to align teams and streamline workflows.">
  • Support design transfer to enable successful commercialization of complex products.">
  • Use systems thinking to design complex platforms integrating equipment, software, and disposables.">
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Requirements

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  • Bachelor's degree or equivalent in Engineering.">
  • Minimum 7-9 years of engineering experience, preferably in the medical device field.">
  • Proficient in configuration management for complex medical device platforms.">
  • Knowledgeable in evaluating designs for serviceability and manufacturability.">
  • Awareness of EUMDR, FDA QSR for technical documentation, labeling, and clinical evaluation.">
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