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# Manager, Systems Engineering, Point-Of-Care

- **Company:** Quidelortho Corporation
- **Location:** San Diego, CA, United States
- **Experience:** Expert
- **Salary:** $165,000.0 - $180,000.0
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Firmware, Software Requirements Analysis, Software Systems, Verification and Validation (Software), Integration Tests
- **Published:** October 9, 2026
- **Apply:** https://startup.jobs/sr-manager-systems-engineering-point-of-care-ortho-clinical-diagnostics-i-8727584

## About the Role

* Minimum of 10+ years' experience with bachelor's degree in engineering or related field, master's degree preferred; and/or equivalent combination of education and experience.
 * Proven track record of successfully bringing medical devices or Point of Care IVD instruments Demonstrated experience leading a systems design effort from concept to commercial launch in a regulated environment.
 * Experience in medical devices/diagnostics and regulated environments
 * Experience managing external development partners and/or working with contract manufacturing partners
 * Experience and training in a specific discipline such as Mechanical,
 * Electrical, Fluidics or SW engineering working knowledge in both hardware and software systems
 * Strong Familiarity with ISO 13485, IEC 62366, IEC 60601, ISO 14971 standards
 * Understanding of verification and validation strategies for complex systems
 * Proven ability to lead without direct authority and influence cross-functional teams
 * Strong communication, analytical, and teamwork skills
 * Ability to travel up to 10%
 * This position is not currently eligible for visa sponsorship.

## Description

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager, Systems Engineering, supporting our Point-of-Care instruments.

This Senior Manager of Systems Engineer provides technical leadership and accountability for the development of complex, multi-disciplinary systems-spanning hardware, software, consumable and assay integration in complex diagnostic systems. The role will lead system design efforts to collaborate with engineers, scientists, and cross-functional partners to investigate, design, and resolve system- level technical challenges.

This position will be onsite full-time in San Diego, CA (Summers Ridge - Sorrento Valley).

The Responsibilities

Systems Engineering & Integration

 * Systems lead in new product development programs
 * Systems Engineering subject matter expert within systems team
 * Oversee the architecture, integration, and verification of complex diagnostic systems, ensuring alignment with product requirements and regulatory standards.
 * Manage integration activities between external hardware/firmware development partners and internal software engineering teams
 * Ensures accurate documentation of system requirements, interface specifications, and integration test plans data, and decisions
 * Provides solutions to complex system-level technical problems
 * Collaborates cross-functionally to define, decompose, verify, and validate system requirements
 * Conduct system level risk analysis and ensure mitigation strategies are implemented
 * Ensure compliance with relevant ISO standards (ISO 14971, IEC 62366, IEC 60601, etc.)
 * Interfaces with manufacturing partners for effective system design transfer

Cross-Functional Leadership

 * Serve as the technical liaison between partners and internal teams
 * Technical Lead for cross-functional project teams including but not limited to R&D, Quality, Manufacturing, Regulatory, Clinical Affairs.
 * Facilitate effective communication and problem-solving across distributed teams
 * Drive technical decision-making and resolve integration challenges
 * Present technical updates to senior leadership and stakeholders

Mentorship and Technical Guidance

 * Mentor and provide technical guidance to junior engineers on system engineering principles and best practices
 * Foster a culture of continuous improvement and technical excellence
 * Keep abreast and share knowledge of updates to technical standards
 * Perform other work-related duties as assigned., Internal Partners:
 * Engineering Team
 * Program Managers
 * Assay Development Scientists
 * Manufacturing Team
 * Design Quality
 * Regulatory Affairs

External Partners:

 * Contract design and manufacturers
 * Electrical Safety Test Contacts
 * Vendors