Lead Systems Engineer at CellFE
Alameda, CA, US

CellFE is a venture-backed company with a mission to make advanced therapies accessible to all by transforming the way gene therapies are manufactured. The company uses a microfluidics-based cell engineering platform that can be adapted universally to enable low-cost, high-yield manufacturing of gene therapies at scale. Our values guide our work: There is a way, Pull together, and Hard work.

CellFE develops and utilizes proprietary microfluidic cell transfection technology for intracellular delivery of diverse genetic payloads to address the needs of contract manufacturers and pharmaceutical companies that specialize in ex-vivo cell therapy.


Position summary: We are seeking a highly motivated Lead Systems Engineer, who thrives in a fast-paced R&D environment, thinks out-of-box and equally revels in autonomy and teamwork. The Lead Systems Engineer is responsible for leading the systems engineering efforts within the organization. The Lead Systems Engineer will collaborate with the Engineering Team in the development and production of CellFE VECT products and will report directly to the Head of Product Development. To be successful in this role, individuals must be driven to innovate and have an extensive experience in all aspects of design and development process.


Preferred expertise:

  • Extensive understanding of medical device product development process (from feasibility to product launch)
  • Design verification and validation for Medical Devices
  • Design transfer
  • Good understanding of quality management systems (ISO13485, ISO9001, 21 820 CFR)
  • Experience with both regulated and unregulated medical devices
  • Good understanding of fluidics
  • Good understanding of Risk Management Process and regulations (ISO 14971)
  • Work experiences with small- & large-scale medical grade vendors (injection molding, bonding, assembly, packaging, and sterilization)

Key responsibilities:

  • Lead systems architecture and system integration effort
  • Lead design verification and validation effort
  • Lead requirement management
  • Play a key role in risk management file creation
  • Assist in design and process characterization activities
  • Help to host supplier quality audits
  • Manage multiple projects and prioritize effectively
  • Cost reduction effort toward overall product design
  • Work with Product development team and medical grade vendors to improve reliability and manufacturability of advanced consumables
  • As part of the team, help to improve and optimize a microfluidics-based consumable device

Qualifications:

  • BS in mechanical engineering, physics, bioengineering, biomedical engineering, or related field preferred
  • 5+ years of work-related experience
  • Demonstrated strong problem-solving skill
  • Ability to collaborate with interdisciplinary teams with a clear vision and plan
  • Ability to work effectively under a fast-paced and constantly evolving environment

Competencies:

  • Strong organizational, planning, and follow-up skills
  • Strong interpersonal communication (written and verbal)
  • Effective problem-solving skills; results-oriented
  • Outstanding attention to details
  • Creative and innovative thinker

The statements above are intended to describe the general nature and level of work performed. It is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.


CellFE is an equal opportunity employer