Systems Engineer

Exthymic•San Diego, CA

18d•$115,000 - $135,000

About The Position

Exthymic is an early-stage deep-tech startup focused on making curative cell therapies widely accessible to prevent cancer deaths. Our platform facilitates the manufacturing of patient-specific treatments at the point of care. We combine hardware, software, and biochemical engineering to innovate in healthcare. The Systems Engineer will maintain a unified system vision, ensure requirements are met and managed, and translate user needs into design inputs. This role involves defining and managing interfaces between various subsystems (mechanical, electrical, fluidic, software, cell biology) to enable parallel development and minimize integration risks. The engineer will also support verification and validation planning, maintain system risk analyses, and ensure risk mitigations are incorporated into requirements. Additionally, the role includes assisting with prototype assembly and testing, feeding learnings back into requirements and interfaces, and contributing to program planning and risk identification.

Requirements

Bachelor's or Master's degree in an engineering or scientific discipline, or equivalent industry experience.
Typically 5+ years at the intersection of biology, chemistry, and instrumentation.
Systems engineering experience building and maintaining a requirements set in a requirements management tool (e.g., DOORS, Jama, Flow Engineering), ideally through the transition from research to product development.
Experience keeping multiple engineering teams aligned: running design reviews, resolving requirement conflicts, and settling interface disagreements.
Experience working within a QMS, including design history files and supporting design artifacts.
Hands-on laboratory experience and comfort collaborating with bench scientists.

Nice To Haves

Experience in cell therapy manufacturing or another regulated bioinstrumentation product.
Track record working in an interdisciplinary R&D / early product development setting.
Familiarity with model-based systems engineering (MBSE) methods and tools.
Experience using AI tools in engineering work, such as requirements drafting, documentation, and/or literature review.

Responsibilities

Keep one shared picture of what the system must do.
Ensure that requirements are being addressed and defined in development, and track them in a requirements management tool.
Translate market and user needs into clear, testable design inputs across biology, hardware, and software.
Define and maintain the interfaces between mechanical, electrical, fluidic, software, and cell biology subsystems.
Maintain the interface control documents and system block diagrams.
Raise integration risks while they are still cheap to fix.
Support verification and validation planning at the subsystem and system level.
Maintain the system risk analyses that drive verification and validation.
Make sure risk mitigations land in the requirements and get verified.
Work with quality and regulatory to keep DHF artifacts current as designs settle.
Help with prototype assembly and testing.
Work alongside the engineering and biology teams on builds and test runs, and feed what you learn back into the requirements and interfaces.
Contribute to program planning and milestone tracking with the functional leads.
Flag schedule and technical risks early.