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

Ortho-Clinical Diagnostics, Inc.; San Diego (CA); On-site; CAD 235,000 - 257,000; Full time

Job summary

QuidelOrtho is seeking a Senior Manager of Systems Engineer to provide technical leadership for complex diagnostic systems, spanning hardware, software, and assay integration. This role collaborates with engineers, scientists, and cross-functional partners to resolve system-level challenges and ensure regulatory compliance.

The position is onsite full-time in San Diego, CA (Summers Ridge – Sorrento Valley) and requires 10+ years of experience in engineering in regulated environments, with strong

Qualifications

• 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 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, including working with contract manufacturing partners.

Responsibilities

• Lead system design efforts for cross-functional teams including R&D, Quality, Manufacturing and Regulatory.
• Oversee architecture, integration, verification of complex diagnostic systems and ensure regulatory alignment.
• Mentor junior engineers and drive continuous improvement in system engineering practices.

Skills

Systems engineering

Regulated environments

Cross-functional leadership

Vendor management

Communication skills

Education

Bachelors in Engineering

Master's degree preferred

Job description

The Opportunity

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 answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

At QuidelOrtho , we’re advancing the power of diagnostics for a healthier future for all.

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.

The Individual

Required:

• 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.

The Key Working Relationships

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

How We Work

• Thrive Together – Collaborate intentionally, grow as a team
• Make It Happen – Focus on priorities, embrace continuous improvement
• Commit to Service – Cultivate a service mindset
• Embrace Inclusion – Be open and authentic, welcome diverse perspectives

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines

Physical Demands

No strenuous physical activity 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.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $165,000 to $180,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [e-mail].

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