Head of Systems Engineering

Cellanome•San Diego, CA

About The Position

We are seeking a hands-on leader for our Head of Systems Engineering to own the system architecture, technical budgets, and system-level verification and validation for the R3200 instrument platform, from current production configurations through the next generation architecture. This role reports to the SVP of Product Development and is a member of the Product Development leadership team. The person in this seat will define how the discipline operates, expands the team that runs it, and be accountable for whether our platforms meets their specifications and whether those specifications reflect what customers actually need.

Requirements

Degree in Engineering (Electrical, Mechanical, or Optical), Bio-engineering, Physics, or Biophysics.
Typically requires a minimum of 20 years of progressive experience in engineering, with 12+ years of leadership experience.
Proven history of key contributions to successful products from early stage to product launch and support of on-market products.
Advanced project management and phase gate development understanding and capability.
Working knowledge of quantitative design and process tools, including (p)FMEA, tolerance analysis, design of experiments (DoE), statistical process control (SPC), GR&R, and Cpk.
Demonstrated experience developing requirements and specifications and architecting complex scientific systems.
Strong communication skills and excellent attention to detail.
Experience with scientific computing tools (e.g. Python, R, Matlab).
Demonstrated ability to perform the Essential Duties of the position with or without reasonable accommodations.

Nice To Haves

PhD preferred.
Familiarity with optical, electrical, mechanical, and fluidics design and corresponding software.
Familiarity with molecular biology or cell biology.
Experience working under a formal design control or quality management system (ISO 13485, IEC 62304, or FDA 21 CFR 820).
Significant experience managing third party development and contract manufacturers.
Hands on experience with design software (SolidWorks, Zemax, OnShape, ePDM) is a plus.

Responsibilities

Create and own system models, define technical budgets, and use these tools to guide system and sub-system architecture decisions and manage tradeoffs.
Develop and implement system and subsystem level interfaces, test strategies and plans.
Drive fundamental understanding of complex systems which bring together hardware, consumables, chemistry, complex assays, analysis, bioinformatics, and cell biology.
Leverage insights of system fundamentals to improve performance, and to architect next generation systems.
Own system-level verification and validation strategy, including protocol definition, execution oversight, and the supporting documentation that carries the platform through phase-gate reviews.
Drive design transfer to manufacturing, partnering with Operations, suppliers, and contract manufacturers to move systems from prototype through pilot builds to volume production, including process capability and yield improvement.
Partner with technical leaders and executive leadership to prioritize R&D initiatives and guide product roadmaps.
Hold make versus buy authority for subsystem development.
Select and manage external design houses and specialty suppliers.
Define statements of work, technical acceptance criteria, and milestone structures for third party development.
Approve or reject deliverable acceptance.
Own the bill of materials cost target from the systems side and drive the cost reduction roadmap with Operations and Supply Chain through component consolidation, tolerance relaxation where the error budget allows, and design simplification.
Own the system requirements architecture: the hierarchy from user needs through system, subsystem, and component requirements, with traceability maintained from each requirement to its verification evidence.
Own system-level risk management: system FMEA, hazard analysis, and the traceable link from identified risk through mitigation and verification to residual risk acceptance.
Establish design review cadence and standards, and enforce them across hardware, consumables, assay, software, and analysis contributions to the system.
Define and publish the systems engineering metrics that feed PDP stage gate reviews: requirement stability over time, verification coverage and first-pass rate, open system-level issues by severity, and specification margin at design freeze.
Set and own reliability targets (MTBF, uptime, mean time to repair) and the reliability growth plan to reach them: accelerated life testing, HALT and HASS where warranted, duty cycle definition, and wear-out characterization of consumable-contacting components.
Own the system-level failure mode catalog.
Drive root cause analysis and corrective action for field failures with Service and Quality, and close the loop back into design.
Own the system-level control strategy that holds performance in specification across instruments, consumable lots, and time: calibration scheme, reference standards, drift monitoring, and the acceptance criteria for instrument release and periodic requalification.