Systems Engineering Manager | GenomeWeb

Systems Engineering Manager

Job Location
Menlo Park, CA
Job Description

The Systems Engineering Manager is a key technical leader responsible for implementing and executing Systems Engineering practices and processes in support of the development of products across the BD Genomics organization.  Through a combination of direct participation and indirect guidance, the SE Manager will ensure the timely and effective execution of system development activities such as system definition and architecture, systems integration, and systems characterization and verification.  The SE manager will also act to identify and implement best practices for Systems Engineering as well as being primarily responsible for training and coaching staff members on these practices.
Primary Responsibilities

  • Acts as an advisor to staff members to meet schedules and resolve technical or operational problems during the Definition, Integration, Characterization and Verification Phases of products under development.
  • Works closely with R&D leadership to help define and meet deliverables for functional excellence.
  • Works with system experts to review integration, characterization, and test strategies and data for new product design at the subsystem and system levels.
  • Frequently interacts with other functional group leaders to ensure that systems under evaluation meet design input specifications and customer needs.
  • Manages within budgetary boundaries defined by the fiscal year budget and quarterly forecasts. Recommends and initiates changes to company practices to improve processes and support regulatory compliance requirements.
  • Reviews systems product development, verification and validation documentation according to Quality Systems Regulations, Standard Operating Procedures and ISO guidelines for design control.
  • Works on complex problems where analysis of data requires an in-depth evaluation of various factors. Normally receives no instruction on routine work, and general instructions on new assignments.

Duties & Responsibilities

  • Systems Lead to oversee and drive process and practice on requirements, risk management, test, characterization, and verification across BD Genomics development groups.
  • Oversees and develops Systems Engineering capabilities within the development teams across BD Genomics.
  • Drives process and practice in the following key areas:
    • Requirements generation and management
    • Risk analysis and management
    • Test, characterization, and verification methodologies
    • Systems integration
    • System definition and architecture
    • Interface definition and management
    • Error budget analysis
  • May serve as Core Team Member on some programs and own the execution of Systems Engineering deliverables.
  • Will act in advisory capacity on other programs in order to support, guide, and review Systems Engineering activities.
  • Works to drive systems knowledge and skills into development organization and raise level of capability across all sites. Identifies and initiates training activities as necessary.
  • Provides hands-on contributions where necessary and appropriate.
  • Based in Menlo Park, CA with expectations of 30% travel to other international sites.
  • Technical leadership role at outset; may include direct people leadership as organization grows.
  • A minimum of a bachelor's degree required. Advanced degree preferred.
  • A minimum of 10 years of experience in the development of complex instrumentation systems.
  • Prior people management experience is an asset.
  • Demonstrated expertise with system development lifecycles and Requirements Development for complex systems. Experience in customer, system and subsystem level requirements generation, management, and traceability (preferably with the use of a requirement tool).
  • Experience with development of test & verification methodologies, root cause analysis, FMEA.
  • Effective interpersonal, leadership and influencing skills.
  • Ability to work effectively with teams across multiple international locations.
  • Superior multi-tasking capabilities, organizational skills and flexibility.
  • Demonstrated ability to communicate technical ideas clearly, both orally and in writing.
  • Effective presentation skills.
  • Demonstrated capability of rapidly coming up to speed with new technologies and systems.
  • Effective analytical, quantitative, and problem solving skills.
  • Knowledge of statistics and experimental study design.
  • Experience working in an FDA (or similar) regulated environment.
  • Knowledge of Design for Six Sigma concepts a plus.
  • Knowledge of Quality Systems Regulations, ISO guidelines, and Good Laboratory Practices.
  • Previous experience working in Life Science or Medical domain a plus.  Knowledge of Next Generation Sequencing and molecular biology a plus.
  • Demonstrated technical skills in several of the following areas: digital and analog electronics engineering, printed circuit board design, thermal design, optics, fluidics, hardware, sheet metal/plastics, human factors engineering, usability testing, systems engineering and system reliability and assay development.
  • Ability to create, maintain and improve product development processes and documents including SOPs and desk procedures.


Regeneron Pharmaceuticals comes out on top of Science Careers' ranking of best biotech and pharma employers.

A researcher recounts in Science how she got her career off the ground.

Bitesize Bio offers some word of wisdom for designing a new lab.

A study finds that some women choose science majors later in their college careers.