Systems Design Specialist

3 days ago

Thiruvananthapuram, Kerala, India beBeeSystemEngineer Full time ₹ 55,00,000 - ₹ 85,00,000

Job Overview:

We are seeking a highly skilled technical professional to lead the design and development of complex medical devices. As a Senior Systems Engineer, you will be responsible for translating user needs and business requirements into product specifications that drive design, implementation, testing, and delivery of safe and compliant products.

Key Responsibilities:

  • Translate user and business requirements into detailed product requirement specifications and design specifications.
  • Apply comprehensive 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 with cross-functional teams to integrate mechanical, electrical, and software components, achieving functional and reliability goals.
  • Develop and implement design changes to enhance features for blood collection platforms, ensuring quality and regulatory compliance.
  • Conduct technical reviews with stakeholders to meet project design objectives.
  • Analyze failures to prioritize testing and ensure design completeness and product quality.
  • Communicate effectively to align teams and streamline workflows.
  • Spearhead design transfer to enable successful commercialization of complex products.

Required Skills and Qualifications:

  • Extensive knowledge of medical device development standards.
  • Proven track record in leading cross-functional teams.
  • Excellent communication and collaboration skills.
  • Ability to analyze complex problems and develop effective solutions.
  • Familiarity with Lean and Six Sigma principles.

Benefits:

  • Opportunity to work on cutting-edge medical devices.
  • Collaborative and dynamic work environment.
  • Ongoing training and professional development opportunities.

Other Duties and Responsibilities:

  • May have work direction responsibility over technicians and junior engineers.
  • May contribute to the establishment of business objectives, goals, budgets, and costs.

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