Terumo Blood and Cell Technologies

Senior System Engineer

Terumo Blood and Cell Technologies

full-time

Posted on:

Location Type: Office

Location: Thiruvananthapuram • India

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Job Level

Senior

About the role

  • Senior systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components.
  • Practice design controls in compliance with the quality management systems to deliver on products that are effective, safe and compliant.
  • Coordinate the design activities in collaboration with various stakeholders including mechanical, electrical, software, quality, manufacturing and commercial Teams.
  • Independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team.
  • 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.
  • 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.
  • Apply knowledge of manufacturing processes tailored to diverse product types like electronics, mechanical design and plastics.
  • Define and manage project scope to optimize resources and avoid scope creep.
  • Lead defect management meetings to achieve actionable outcomes and maintain good documentation practices.
  • Develop and approve test protocols to ensure functional testing and maximize reuse for multiple configurations.
  • Apply Six Sigma and Lean principles to enhance efficiency and minimize waste.
  • Define integration and verification plans with experience in budgeting adequate resources and time for execution of the plans.
  • Create, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR).
  • Conduct Technical reviews to root cause issues, perform tradeoff analysis, document key design considerations for future reference.

Requirements

  • Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
  • Minimum 5+ years of Engineering experience is required for a Senior System Engineer.
  • Minimum of 4 years Systems Engineering experience in the medical device field preferred.
  • Proficient in configuration management for complex medical device platforms including hardware, software and disposables.
  • Knowledgeable in evaluating designs for serviceability and manufacturability.
  • Practice the creation, maintenance of Design History files for medical device products.
  • Awareness of EUMDR, FDA QSR for technical documentation, labeling and clinical evaluation.
  • Develop and oversee test methods to demonstrate the design has implemented the necessary functionality.
  • Conduct design analysis necessary to evaluate the completeness of specifications, testing.
  • Utilize failure analysis to determine if the designs are effective in meeting the user and business needs.
  • Evaluate the designs for serviceability and manufacturability.
  • Mentor junior engineers on the practice of systems thinking.
  • Manage projects independently to lead changes to existing features and incorporate new features for the product platforms used in collecting blood and blood components.
  • Experience in conducting risk analysis for defects to demonstrate the safety and efficacy of medical device platforms.
  • 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 the complex design using tools like CATIA Magic Cyber Systems Engineer, PTC Modeler or Enterprise Architect.
Benefits
  • Requires travel based on business needs.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
systems engineeringdesign controlsfailure analysisrisk analysistest protocolsconfiguration managementdesign analysisSix SigmaLean principlesmanufacturing processes
Soft Skills
collaborationcommunicationleadershipproject managementmentoringstakeholder engagementproblem-solvingteam alignmentworkflow optimizationdefect management
Certifications
ISO 13485ISO 14971IEC 62304IEC 62366IEC 60601