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Principal Software Systems Engineer

Alcon develops and manufactures innovative devices for eye care needs, including surgical equipment for cataract removal and laser vision correction, and consumer products like Opti-Free contact lens solutions.
Lake Forest, CA, USA
$104,000 - $156,000
Embedded
Principal Software Engineer
In-Person
5,000+ Employees
8+ years of experience
Healthcare · Medical Devices

Job Description

Alcon, a global leader in eye care with over 25,000 associates, is seeking a Principal Software Systems Engineer for their medical digital platform solutions. This role, based in Lake Forest, CA, is crucial for developing medical device software systems while ensuring compliance with regulatory standards. The position sits within Alcon's Information Technology function, working on cutting-edge technology solutions for eye care.

The role demands expertise in software development life cycles, systems engineering, and medical device regulations. You'll be responsible for writing system requirements, managing the Design History File, and implementing risk management processes. Working in a pod-structured environment, you'll collaborate with various teams including UI/UX, QA, Product, and R&D.

This is an excellent opportunity for an experienced software systems engineer looking to make a significant impact in medical device development. The position offers competitive compensation ($104,000 - $156,000) and comprehensive benefits including health insurance, retirement plans, and flexible time off. You'll be part of a company committed to enhancing sight and helping people see brilliantly, with products sold in 180 countries worldwide.

The ideal candidate will have 8+ years of experience, strong expertise in medical device software development, and a deep understanding of regulatory requirements. This role combines technical leadership with cross-functional collaboration, making it perfect for someone who enjoys both technical challenges and team coordination.

Last updated 24 days ago

Responsibilities For Principal Software Systems Engineer

  • Collaborate with product team, UI/UX team, scrum master, and program manager for system requirements
  • Act as primary liaison between development team and other departments
  • Write system requirements and specifications (SYRS) and software requirements (SRS) for medical devices
  • Manage Design History File (DHF) for digital surgical platform
  • Provide expertise in diagnosing defects and formulating solutions
  • Implement risk management processes and hazard analysis
  • Ensure compliance with industry standards
  • Stay informed about industrial trends in medical software development

Requirements For Principal Software Systems Engineer

  • Bachelor's degree in computer science, biomedical engineering, or related field
  • 8+ years of experience in systems engineering and software engineering
  • Proficiency in Agile software development methodologies
  • Strong system engineering expertise
  • In-depth understanding of regulatory requirements (IEC 62304, ISO 13485, FDA regulations)
  • Ability to lead cross-functional teams
  • Fluent in English
  • Experience with medical device software development

Benefits For Principal Software Systems Engineer

Medical Insurance
Vision Insurance
Dental Insurance
Relocation Benefits
  • Health insurance
  • Life insurance
  • Retirement benefits
  • Flexible time off
  • Relocation assistance

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