Senior Systems Engineer

About Vero-biotech

Our Mission:
At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed.

We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations.

The Senior Systems Engineer – R&D is responsible for owning the system‑level definition, integration, and execution of VERO’s next‑generation platform. This role provides end‑to‑end system ownership, from shaping product features and system requirements informed by user and clinical needs, through verification, validation, and submission readiness. Working closely with Engineering, Regulatory Affairs, Quality, Clinical, Program Management, Operations, and external partners, the Lead Systems Engineer ensures that roadmap decisions, feature trade‑offs, and system‑level requirements translate into disciplined, predictable execution.

• Own system‑level architecture for Gen 4, architectural decomposition, and subsystem allocation, including interfaces across cassette, console, software/firmware, accessories, and external systems (e.g., ventilators).
• Lead engineering integration activities, ensuring assumptions, interfaces, and dependencies are aligned and resolved early.
• Drive system‑level trade studies balancing performance, risk, manufacturability, serviceability, and regulatory expectations.

• Own system‑level requirements, ensuring they are clear, testable, traceable, and aligned with intended use, user needs, and regulatory expectations.
• Partner with engineering, clinical, and product inputs to translate user needs into execution‑ready system requirements.
• Ensure traceability across requirements, risks, verification, validation, and documentation.

• Serve as system‑level risk management owner, including hazard analysis and risk control integration.
• Ensure design control artifacts are complete, consistent, and audit‑ready in partnership with Quality.
• Own the system‑level verification and validation strategy in partnership with V&V Engineering.
• Ensure verification and validation plans align with system architecture, risks, and FDA expectations.
• Lead or support system integration strategy, including protocol scope, test execution readiness, and alignment with FDA feedback.
• Ensure human factors engineering is integrated into system decisions.
• Partner with HF Engineering to incorporate usability risks, critical tasks, and validation inputs.

• Act as the technical integrator for Gen 4 across Engineering, Regulatory, Quality, Clinical, and Operations.
• Partner with Program Management to align dependencies, surface risks early, and support milestone reviews.
• Collaborate with external partners (OEMs, testing labs, HF vendors) as required.

• Bachelor’s degree in Systems, Biomedical, Mechanical, Electrical, or related Engineering discipline.
• 7+ years of experience in medical device or regulated product development.
• Demonstrated experience owning system‑level integration across hardware, software, and clinical workflow.
• Strong knowledge and Class II/III product experience of design controls, risk management, requirements management, and V&V.

• Experience with respiratory devices, ventilators, or combination products.
• Familiarity with FDA expectations for system compatibility and validation.
• Exposure to human factors/usability engineering.
• Regulatory standard familiarity such as ISO 13485, ISO 14971, IEC 62304, etc)
• Experience partnering with Regulatory Affairs and Quality teams on submission readiness.
• Excellent written and verbal communication skills.

The above is intended to describe the general content and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.