Head of Systems Engineering

Cellanome; San Diego (CA); On-site; USD 230,000 - 270,000; Full time

Job summary

Cellanome in San Diego, CA is seeking a hands-on Head of Systems Engineering to own the system architecture for the R3200 platform, manage technical budgets, and lead verification and validation across current and next-generation configurations.

You will shape discipline operations, grow the team, and ensure the platform meets customer needs. The role requires 20+ years in engineering with 12+ in leadership, and strong skills in design control and collaboration with manufacturing and suppliers.

Qualifications

• 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.

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.
• Travel up to 25% of working time away from work location, including overnight/weekend, and/or international travel at time.

Skills

Leadership

Communication

Systems thinking

Problem solving

Cross-functional collaboration

Education

Engineering degree (Electrical/Mechanical/Optical/Bio-Engineering/Physics/Biophysics)

PhD preferred

Tools

SolidWorks

Zemax

OnShape

ePDM

Job description

We’re a well-funded start-up. You’ll get a chance to wear many hats, be a part of a growing team, and have the potential for exciting financial and career growth.

Here’s what sets us apart. We’ve set our sights on some of the biggest challenges facing biology today. We’re amassing a world class team of engineers, scientists, team builders and problem solvers to tackle these challenges heads-on. We’re passionate about developing the next generation technologies that will unravel the complexities of biology.

This is a unique opportunity to build, be part of an exciting start-up and be surrounded by good humans who are super capable, humble and down-to- earth.

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.

Essential Duties include but are not limited to the following:

• 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.
• Ability and willingness to travel up to 25% of working time away from work location, including overnight/weekend, and/or international travel at time.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

The estimated base salary range for this position is $230,000 - $270,000/year. Within the range, individual pay is determined by work location and additional factors including job related skills, experience, and relevant education or training.

What You Can Expect From Us

You’ll feel the energy when you walk in our door – we work hard, we have fun and we have ambitious plans to grow. Cellanome offers a comprehensive employment package that includes a competitive salary, generous stock options, great individual, and family health plans, a 401(k) and flexibility to balance work and life.

We embrace and celebrate the diversity of our employees. We are committed to equal employment opportunity regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, veteran status, or other class protected by applicable law. We are proud to be an equal opportunity workplace.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.