Leading Medical Device Design Engineer

7 days ago

Thiruvananthapuram, Kerala, India beBeeSystemEngineer Full time ₹ 18,00,000 - ₹ 25,12,000
Job Description

A senior systems engineer is responsible for translating user needs and business requirements into product specifications, driving design, implementation, and testing of medical devices for blood collection.

Key Responsibilities:

  • Translate user and business requirements into detailed product requirement specifications and design specifications.
  • Apply design controls with 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.

Requirements:

  • Bachelor's degree or equivalent education and experience in engineering.
  • Minimum 7-9 years of engineering experience for a Senior System Engineer and 5-7 years for a System Engineer.
  • Four years of systems engineering experience in the medical device field preferred for Sr. Engineer and 2 years experience for System Engineer.

The ideal candidate will have proficiency in configuration management, knowledge of evaluating designs for serviceability and manufacturability, and awareness of EUMDR, FDA QSR for technical documentation, labeling, and clinical evaluation.

Preferred Skills

  • Proficient in using requirements management tools like Doors, Windchill RV&S.
  • Proficient in using test management tools like ALM for test case management.
  • Experience in using SysML for describing complex design using tools like CATIA Magic Cyber Systems Engineer, PTC Modeler or Enterprise Architect.

Working Conditions

The general labor environment requires use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

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