Principal Engineer Systems

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.
• Strong 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.