Head of Systems Engineering

Job Description

Job Description

We are scientists, engineers, and operators who have spent our careers inside cell therapy manufacturing. We have built the platforms, scaled production, and watched these treatments fail to reach the patients who need them. We are building the technology to close that gap. If this is work you want to do, read on.

About You

You are a technically rigorous and organizationally savvy leader with deep experience translating R&D outputs into disciplined, product-ready engineering. You understand the cadence of both research and product development, and you excel at building the connective tissue between them.

You are energized by ambiguity and thrive in early-stage environments where the playbook is still being written. You have proven experience building and mentoring engineering teams, and you derive satisfaction from developing others’ capabilities. You know how to define and manage processes, set standards that last, and you can do it in parallel with hands-on technical work.

• Define the vision for systems engineering - Partner with leadership on technology strategy, make build-vs-buy decisions for instrumentation capabilities, and represent systems engineering in company-level planning and resource allocation decisions.
• Build and lead the systems engineering function - Establish the systems engineering discipline from the ground up — recruiting, hiring, and mentoring a team that owns integration across mechanical, fluidic, software, and biological subsystems.
• Bridge research and engineering through requirements - Translate fuzzy, evolving research outputs into disciplined requirements that subsystem teams can build against. Partner with scientists and engineers to decompose biological and process performance targets into system-level requirements, flow them down to subsystems, and maintain traceability as the target product profile evolves.
• Define and maintain systems-level design controls - Author and maintain the SRS, ICDs, FMEAs, risk registers, and V&V plans governing our cell processing platform. Ensure design control artifacts are complete, traceable, and audit-ready.
• Own the development cadence - Lead design review at every version increment across all workstreams, and make risk-informed go/no-go calls. Enforce the through-line from requirements to design decisions to test evidence, and prevent silent drift between modules through interface version discipline. As the platform matures, extend this to integration testing and process qualification, and own root-cause analysis when integration issues surface.

• Partner with leadership on product development pacing - Track program-level technical progress against milestones and provide leadership with actionable status on integration readiness and risk exposure. Keep R&D velocity from becoming the pacing constraint.
• Represent Exthymic in regulatory and customer technical interactions - Support FDA interactions, quality audits, and customer technical discussions, translating systems capabilities and requirements to external audiences.

Requirements

Qualifications

• Bachelor's or advanced degree in systems engineering, mechanical engineering, electrical engineering, biomedical engineering, or a closely related discipline.
• At least 10+ years of engineering experience, including 5+ years in systems engineering roles within a hardware-centric product environment, and 3+ years of people leadership.
• Demonstrated experience owning SRS, ICD, FMEA, and V&V documentation in a regulated or semi-regulated context.
• Experience taking a hardware product through full commercialization, including ownership of the design history file, design transfer, and the regulatory documentation burden associated with a first product launch in a regulated or semi-regulated market.
• Excel at communicating technical status and risks to non-technical audiences, including executive leadership and external stakeholders.
• Track record of leading integration programs - scheduling and running design reviews, managing risk registers, and driving qualification campaigns across multidisciplinary teams.
• Capability to work across research and engineering organizations, translating outputs between scientific and product development contexts.
• Strong people leadership experience: hiring, mentoring, and managing engineering teams.
• High tolerance for ambiguity and incomplete requirements; demonstrated ability to set direction and make sound decisions with limited information.

Preferred Qualifications

• Experience in life science instrumentation, medical devices, or laboratory automation — particularly platforms integrating fluidics, biology, and mechatronics.
• Familiarity with IQ/OQ/PQ qualification protocols, design history files (DHF), and 21 CFR Part 820 or ISO 13485 quality systems.
• Experience with FDA regulatory submissions for medical devices.
• Background working in early-stage startups where processes and standards must be built from scratch alongside the product itself.
• Hands-on experience with cell therapy, bioprocessing, or adjacent biological manufacturing workflows.
• Demonstrated use of model-based systems engineering (MBSE) tools or structured requirements management platforms.
• Experience using AI tools to accelerate engineering workflows, including requirements drafting, documentation, literature review, or cross-functional communication.

Benefits

We offer our employees comprehensive benefits, including medical, vision, and dental coverage, as well as retirement savings plans. Optional benefits include Accident and Term Life offerings.

AGENCIES : We work directly with candidates and do not accept unsolicited resumes or referrals from recruitment agencies, search firms, or staffing companies. Any resumes submitted by an agency without a signed agreement in place will be considered the property of Exthymic and no fee will be owed. If you are interested in partnering with us on a future search, please contact our HR team directly.