Manager/ Staff Systems Engineer

Genalyte•San Diego, CA

2d•Onsite

About The Position

The Manager/Staff Systems Engineer will independently apply systems design approaches to projects that have both life science/chemistry and software, instrumentation and engineering components. They lead activities to bridge between development teams and stakeholders to ensure a high quality product development lifecycle. Oversees system level performance product portfolios comprising software and instrumentation, through close collaboration with Lab Operations, software dev, hardware engineering, and other functional groups.

Requirements

Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment required
Master's or higher degree in Engineering including training and experience in systems, electronics, software and mechanical engineering
6+ years of experience leading the architecture and design of products spanning multiple engineering disciplines.
At least 3+ years of experience leading and supporting software product development activities
Possesses a broad knowledge base with strong grasp of engineering principles preferably in life sciences instrumentation and apply this knowledge to address issues from technology development to concept development to product launch
Ability to produce high-quality documentation and figures to describe complex systems concepts and architecture, requirements specifications and other process documents
Excellent communication and interpersonal skills required
Fluent in Python or an equivalent language for engineering problem solving
Experience working with electrical, mechanical, optical, and chemical systems.
Creative individual with strong analytical and problem solving

Nice To Haves

Product development experience in regulated/process driven environments is preferred

Responsibilities

Engage with cross-functional teams including hardware engineering, software engineering, assay development, and external contract engineers to drive system-level performance of Genalyte’s products.
Work with cross-functional teams to establish and refine system level requirements.
Provide product development leadership alongside product development managers to take products from concept to delivery while ensuring quality, extensibility and maintainability
Create input/output relationships (interface definition) between key functional elements and identify constraints w.r.t manufacturability, cost, complexity and risk mitigation
Lead efforts to create, curate and maintain well-formed requirements specifications for software, optics, electronics and embedded, and opto-mechanical sub-systems
Key contributor to the system and sub-system level risk management activities with assigned programs
Contribute to multiple cross-functional projects with an eye on overall system architecture and fulfillment of interface contracts between sub-systems
Provides advice and consultation to engineering teams regarding system engineering principles and system level requirements
Actively participates in decision making processes that involve changes to the system level design