Principal Eng, Systems

The ideal candidate will leverage his/her exposure to embedded software and its interplay with electronics/hardware to support optimal system/product level realization for new products as well as sustenance of the existing products to deliver dialysis therapy. 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 in QA, RA, Clinical, Service, and Manufacturing.

The successful candidate will possess strong technical abilities, excitement and energy for product development, and a passion for their work and the impact it has on extending lives and expanding possibilities. Candidate is responsible for establishing, maintaining, and governing end‐to‐end requirements—from user needs through system, subsystem, and interface specifications—with rigorous traceability, risk alignment, and compliance with medical‐device standards.

Essential Duties and Responsibilities:

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

Work with clinical, marketing, and human‐factors 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 requirement‐related 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).

Desirable:

Awareness of medical devices ISO and IEC design control procedures, regulations and standards.

Working knowledge on dialysis equipment.