Sr. Manager, Systems Engineering, Point-Of-Care

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry, and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing fast, accurate, and consistent testing where and when it’s needed most—from home to hospital, lab to clinic. Our culture prioritizes team member happiness, inspiration, and engagement, fostering meaningful connections to drive both personal fulfillment and business success.

About the role

This Senior Manager of Systems Engineering provides technical leadership and accountability for the development of complex, multi-disciplinary diagnostic systems—spanning hardware, software, consumable, and assay integration. The role leads system design efforts, collaborates with engineers, scientists, and cross-functional partners, and resolves system-level technical challenges. This position is full-time onsite in San Diego, CA (Summers Ridge – Sorrento Valley).

Responsibilities

• Lead system design in new product development programs as the Systems Engineering subject matter expert.
• 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.
• Ensure accurate documentation of system requirements, interface specifications, integration test plans, data, and decisions.
• Provide solutions to complex system-level technical problems.
• Collaborate 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.).
• Interface with manufacturing partners for effective system design transfer.
• Serve as the technical liaison between partners and internal teams.
• Act as Technical Lead for cross-functional project teams including R&D, Quality, Manufacturing, Regulatory, and 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.
• 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 of and share knowledge of updates to technical standards.

Requirements

• Minimum of 10+ years’ experience with a 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 to market.
• 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 Software engineering with 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.

Work Environment

The role operates in a manufacturing, laboratory, or warehouse environment, which may include handling viral and bacterial hazards, potentially hazardous chemicals, and infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time is spent at a desk, standing or sitting for extended periods. Flexible work hours may be required to meet project deadlines.

Physical Demands

No strenuous physical activity is required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation.

Pay

The salary range for this position is $165,000 to $180,000 and is bonus eligible. Compensation decisions depend on education, experience, knowledge, skills, geography, and internal equity.

Benefits

• Comprehensive medical, dental, and vision insurance.
• Life and disability insurance.
• 401(k) plan.
• Employee assistance program.
• Employee Stock Purchase Plan.
• Paid time off (including sick time).
• Paid holidays.