System Requirement Engineer - Medical Domain
- Siemens
- 6 - 8 years
- Bengaluru
- 3 years ago
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Job Description
Your tasks and responsibilities: You will be responsible for owning and maintaining system level functional requirements of existing medical device product in field.
You will be responsible for owning system level functional requirements of new features and the verification of development results related to these requirements.
You will establish traceability between system functional specifications requirements and its source requirements.
You will be responsible for keeping the project specific requirements management plan up to date and maintain the requirements management environment.
You will be responsible to create a traceability report at defined R-reviews showing that requirements tracing is complete.
You will lead the Change Control Board (CCB) and be responsible for defect management process.
Support Risk Engineer with the Product risk management on system level till R6.
Support in Risk Assessment of defects Support the requirements development of a Clinical Workflow for technical feasibility and review the requirement specification.
Good understanding of Design Transfer process.
Prepare design transfer documentation and database entries (e.g., in SAP) as needed.
Analyze project ideas and proposals for feasibility and impact on existing commitments.
Analyze complaints receive from fields and support in RCA evaluation.
Close collaboration with Product Management, Test Center, Development Team Members, and Supply Chain Management colleagues.
Your qualifications and experience: Bachelor s Degree in Biomedical Electronics/Engineering, Electrical Engineering, Systems Engineering, or related field required.
6-8 years.
You have many years of professional experience in product development of medical systems Working experience in a agile development environment is a plus.
You have gained working experience with Medical Device Regulation (MDR), 21 CFR PART 820 and MDD You have in good knowledge and understanding of IEC, EN and ISO standards for medical Devices You have gained working experience in Product Risk Management process You have good level understanding of SDLC process and IEE 29148 - International Standard - Systems and software engineering -- Life cycle processes -- Requirements engineering Your attributes and skills: Your excellent fluency in English enables you to collaborate with your international colleagues Your strong analytical and results-oriented mindset, as well as your ability to drive reliable decision-making, set you apart from the rest You have outstanding communication, facilitation and coordination skills; working with intercultural and interdisciplinary teams comes easily to you.
"Today is about tomorrow": you are highly motivated to drive change that supports ongoing optimization
Job Classification
Industry: Industrial AutomationFunctional Area: Engineering - Software,
Role Category: Software Development
Role: Software Development
Employement Type: Full time
Education
Under Graduation: Any GraduatePost Graduation: Any Postgraduate
Doctorate: Doctorate Not Required, Any Doctorate
Contact Details:
Company: SiemensLocation(s): Bengaluru
Keyskills: Product management Supply chain management SAP ISO Risk assessment Analytical Workflow Healthcare Risk management SDLC
Siemens
Siemens Limited Siemens Information Systems Ltd. (SISL) was incorporated in 1992. It has grown on to become a leading system integrator and total solution provider to a host of Global Clientele and its business has grown over 100% in the last three years through consistently delivering higher va...
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