Senior Systems Engineer
- Terumo Penpol
- 6 - 10 years
- Thiruvananthapuram
- 1 month ago
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Job Description
SYSTEM ENGINEERING
JOB SUMMARY-
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. Senior systems engineer will practice design controls in compliance with the quality management systems to deliver on products that are effective, safe and compliant. In this role you are expected to coordinate the design activities in collaboration with various stakeholders including mechanical, electrical, software, quality, manufacturing and commercial Teams. As a senior systems engineer you are expected to 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
ESSENTIAL DUTIES
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.
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.
Skills
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.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Research & Development - OtherRole: Research & Development - OtherEmployement Type: Full timeContact Details:
Company: Terumo PenpolLocation(s): Thiruvananthapuram
Keyskills: Sysml System Engineering Model Based System Engineering Windchill Alm
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Terumo Penpol
https://www.terumobct.com/ We Are a Terumo Group Company. Terumo was founded in 1921 by a group of medical scientists led by Dr. Shibasaburo Kitasato, for the purpose of manufacturing reliable clinical thermometers in Japan. For over a century, Terumo has continued to contribute to society throu...
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