Genalyte

Manager/ Staff Systems Engineer

Genalyte$150K — $175K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Experience in medical devices, diagnostics, or healthcare technology in regulated environments.
  • Master's degree or higher in Engineering with systems, electronics, software, and mechanical focus.
  • 6+ years leading product architecture/design across multiple engineering disciplines; 3+ years in software development.
  • Experience in regulated/process-driven environments preferred.
  • Strong understanding of engineering principles, especially in life sciences instrumentation.
  • Ability to produce high-quality technical documentation and visual aids.
  • Proficiency in Python or equivalent programming language for problem-solving.

Responsibilities

  • Engage cross-functional teams to enhance system-level product performance.
  • Refine system-level requirements through collaborative efforts.
  • Lead product development from concept to delivery, emphasizing quality and maintainability.
  • Define input/output relationships and identify constraints in design.
  • Maintain comprehensive requirements specifications for multiple sub-systems.
  • Contribute to risk management for system and sub-system levels in assigned programs.
  • Advise engineering teams on systems principles and design changes.

Benefits

  • Comprehensive benefits package including health, dental, and vision insurance.
  • Flexible time off policy for work-life balance.
  • Opportunities for meaningful equity participation and bonuses.
Full Job Description
POSITION SUMMARY

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.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to:
  • 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

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS & ABILITIES
  • 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
  • Product development experience in regulated/process driven environments is preferred
  • 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

TRAVEL REQUIREMENTS

Minimal; occasional travel to meet with contract engineering partners, (
PHYSICAL REQUIREMENTS & WORK ENVIRONMENT

This is a primarily office-based role in San Diego, CA. Occasional visits to laboratory and engineering environments may be required.

COMPENSATION

The base salary range for this role is $150,000 - $175,000 per year. Individual pay may vary based on job-related skills, experience, and relevant education or training. In addition to base salary, this role includes meaningful equity participation, eligibility for the target bonus plan, and a comprehensive benefits package (health, dental, vision, and flexible time off policy).

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