Vantive Health - Senior Engineer - Embedded System

JOB TITLE : Senior Engineer, Systems.

JOB LOCATION : Whitefield, Bengaluru.

Summary :

The Senior Systems Engineer will apply deep experience in electromechanical systems to drive optimal system and product-level design, integration, and realization for both new product development and sustenance of existing dialysis therapy platforms.

In this role, you will be part of the Systems Engineering function within the broader R&D organization, collaborating closely with cross-functional teams including Software, Hardware, V&V, and Digital Engineering, as well as global stakeholders across QA, RA, Clinical, Service, and Manufacturing.

The ideal candidate brings strong technical depth, systems thinking ability, and a proactive problem-solving mindset. You demonstrate passion for innovation, product development, and building healthcare technologies that positively impact patient lives.

Key Responsibilities :

- Collaborate with cross-functional teams to deliver projects of minor to moderate complexity.

- Drive system-level design, integration, and realization activities for medical device platforms.

- Support product sustenance and engineering change activities for existing products.

- Create, analyze, and manage product/system requirements and traceability.

- Participate in risk management activities including : Risk Analysis Hazard Mitigation Design Risk Assessments FMEA/FMECA Analyze risk mitigations and associated design features within system architecture.

- Perform system integration, verification, and testing activities.

- Leverage understanding of technology, process, and therapy domains to support product realization.

- Participate in design reviews and ensure incorporation of cross-functional inputs.

- Drive resolution of technical issues and system-level engineering challenges.

- Contribute to subsystem ownership or act as SME for technical problem-solving.

- Support technical strategy and continuous product improvements.

- Ensure compliance with medical device design controls and engineering standards.

Required Skills & Technical Expertise :

Core Systems Engineering Skills :

- Strong experience in : Systems Engineering Product Integration Electromechanical Systems Product Sustenance Engineering Requirements Engineering Risk Management System Verification & Validation

Relevant Technical Stacks & Tools :

- Requirements Management Tools : IBM DOORS Polarion Jama

- System Modeling & Architecture : SysML UML Enterprise Architect MATLAB/Simulink

- Risk & Quality Tools : FMEA/FMECA Fault Tree Analysis (FTA) CAPA Root Cause Analysis

- Test & Validation Tools : NI LabVIEW TestStand Hardware-in-the-Loop (HIL) Testing

- Embedded & Hardware Exposure : Embedded Systems Basics Sensor Integration Signal Processing Concepts Analog/Digital Interfaces

- Software & Automation Exposure : Python MATLAB Shell Scripting Basic C/C++

- Configuration & Lifecycle Management : Git Jira Azure DevOps ALM/PLM Tools Medical Device & Regulatory Knowledge

- Awareness of : ISO 13485 IEC 60601 ISO 14971 FDA Design Controls IEC/ISO Medical Device Standards

- Understanding of : Medical Device Lifecycle Design Controls Regulatory Documentation Traceability Management

Qualifications :

- Bachelors or Masters degree in related Engineering disciplines 8 to 10 years of experience as a Systems Engineer or similar role.

- Strong analytical, troubleshooting, and problem-solving capabilities.

- Excellent collaboration and stakeholder management skills.

- A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products..

- Excellent communication and coordination skills.