Role & responsibilities :

- Lead development, structuring, and decomposition of requirements for an electromechanical medical device development project.

- Work with clinical, marketing, and humanfactors teams to define and refine user needs, use cases, and product claims.

- Translate system-level needs into functional, performance, interface, and safety requirements across mechanical, electrical, embedded, controls, and software domains.

- Ensure full bidirectional traceability using any requirement management tool, linking requirements to risk controls, architecture, design elements, and verification methods.

- Facilitate cross-functional requirement reviews, ensuring clarity, feasibility, and compliance with relevant medical standards (ISO 13485, ISO 14971, IEC 60601, IEC 62304).

- Maintain configuration control, change management, and version governance of requirement artifacts.

- Support verification planning and coverage analysis ensuring every requirement is testable and aligned with risk and design outputs.

- Collaborate with mechanical, electrical, software, controls, and quality engineering teams to ensure the architecture aligns with requirements.

- Support system-level design documentation (architecture diagrams, interface control documents, hazard analyses, robust requirements).

- Work with risk management teams to ensure requirements address identified hazards, mitigations, and residual risk acceptance.

- Participate in FMEA/FMECA activities and ensure results flow into requirements and verification.





- Support system integration builds, resolving requirement conflicts, clarifying intent, and supporting issue triage.

- Serve as the primary communication bridge across design engineering, quality, regulatory, service, and manufacturing teams for all requirementrelated matters.

- Lead technical discussions, drive alignment, and resolve requirement ambiguities or conflicts proactively.

- Facilitate decision-making, ensuring traceable and documented rationale.

- Mentor junior engineers in requirements management practices and system-thinking principles.

- Ensure all requirements and traceability deliverables meet medical device regulatory expectations.

- Support internal and external audits by presenting requirements, rationale, and traceability artifacts.

- Maintain high documentation quality aligned with design control requirements (21 CFR 820.30, ISO 13485).

Preferred candidate profile

- Bachelors or higher engineering degree in Electrical/Electronics, Computer Science or related discipline.

- 10-15 years of proven experience as a systems engineer or a similar role.

- Proficiency in relevant software & systems, tools, & techniques.

- Robust analytical and problem-solving skills.

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

- Experience in handling the end user/patient needs, operations issues (production, field, supply chain) independently.

📌 Principal Engineer Systems (Bengaluru)
🏢 Vantive Healthcare Technologies
📍 Bengaluru