System engineer

Important points to be Noted:

• Tech/B.E/MSC/MCA - Electronics/software/Electrical (No mechanical)
• Medical device domain experience (Mandatory)
• ISO 14971 Risk Management experience (Mandatory)
• Requirements management & RTM (Mandatory)
• Regulatory compliance exposure (ISO 13485/IEC 62304/FDA/MDR) (Mandatory)
• System Engineering-Product development lifecycle experience (Mandatory)
• Software development/embedded systems experience (Preferred)
• V&V/System Testing experience (Preferred)
• DOORS/Polarion/Jama tool exposure (Preferred)

Key Skills & Competencies

• Proficiency inSystems EngineeringandRequirements Management.
• Strong understanding ofTechnical System Requirements (TSR)and the ability to effectively flow down requirements into detailedSubsystem and Unit-level Requirements.
• Good understanding ofSoftware and Hardware System Architecture.
• Basic domain knowledge in:
  • Electronics
  • Electrical Engineering
  • Embedded Systems
  • Software Development
  • Mechanical Design
• Excellentdocumentation reporting and communication skills.
• Strong collaboration skills with the ability to work effectively incross-functional teams.
• Experience coordinating withexternal test laboratoriesfor compliance testing and certification activities.

Regulatory & Risk Management Knowledge

• Understanding of regulatory compliances and applicable standards forMedical Devices.
• Knowledge ofISO 14971and Medical Device Risk Management processes.
• Ability to identify applicable regulatory requirements and update system documentation accordingly.
• Basic to expert knowledge of relevant medical device regulatory standards.
• Understanding ofFMEA methodologies including:
  • System-level DFMEA
  • Flow-down of risks to subsystem-level DFMEA
• Ability to maintain traceability between:
  • Technical System Requirements (TSR)
  • Technical Sub-System Requirements (TSSR)
  • Risk Management Files

Key Responsibilities

• Author review and maintainTechnical System Requirementsin collaboration with cross-functional engineering teams.
• Update and manage requirements inIBM DOORS(Requirements Management Tool).
• Drive end-to-end traceability from system requirements through subsystem requirements and risk documentation.
• Perform system-level verification activities including:
  • Test case creation
  • Test review
  • Test execution
  • Test reporting
• Develop and maintainSystem Integration Plans test strategies and integration reports.
• Support preparation of documentation forregulatory submissions ensuring compliance with applicable medical device regulations.
• Collaborate with engineering quality regulatory and verification teams to ensure successful product development and compliance.

Preferred Experience

• Experience inMedical Device Product Development.
• Exposure to requirements management tools such asIBM DOORS.
• Hands-on experience insystem verification risk management and regulatory compliance activities.
• Familiarity with medical device standards and product lifecycle documentation.

Required Skills:

System EngineerMedical DevicesISO 14971Risk ManagementRequirements ManagementRTM