Staff Engineer, Systems Integration

Abbott Laboratories; San Diego (CA); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott Laboratories in La Jolla, CA, seeks a Staff Engineer, Systems Engineering to lead system integration for cross‑functional IVD medical devices from concept to manufacturing. You will drive V&V, design reviews, DOE applications, and performance testing while ensuring traceability and regulatory compliance across multiple product lines.

You will collaborate with hardware, software, and reagent teams to deliver robust architectures, detailed System DHF documentation, and effective risk

Qualifications

• 10+ years of experience in the IVD medical device field through a formal NPD process.
• Bachelor’s degree in listed fields and US work authorization.
• Strong technical writing and ability to work independently.

Responsibilities

• Assess design feasibility and test product functionality.
• Lead V&V activities at the system level and ensure traceability of requirements.
• Participate in system architectures and documentation trees.
• Lead system integration during design and V&V phases.
• Collaborate with hardware, software, and reagent teams to implement designs.
• Ensure DHF documentation and regulatory compliance.

Skills

System integration

DOE

V&V

Technical writing

Cross-functional collaboration

Problem solving

Regulatory awareness

Education

Bachelor’s degree (Biology, Biochemistry, Systems Engineering, Biomedical Engineering, Physics, or related)

Advanced degree (Masters/PhD)

Tools

Formal requirements management tools

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION

The Staff Engineer, Systems Engineering is a key problem solver and technical leader to plan and lead the system integration aspects of cross-functional product development projects for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. This position will use expert technical skills to contribute to multiple technologies and product lines across the company. This position will leverage understanding of advanced engineering principles, advanced engineering methods, data, and judgment to influence product concept generation, design reviews, test method development, performance testing, and assessment of system interactions.

Essential Duties Include but are not limited to the following:

• Assess design feasibility and test product functionality and/or confirm product capabilities.
• Responsible for test method development and lead V&V activities at the system level.
• Responsible for traceability of requirements to product design outputs.
• Participate in new product design and design improvements to existing products.
• Participate in the definition and creation of system architectures and documentation trees.
• Lead system integration activities during product design and V&V phases.
• Utilize Design of Experiment (DOE) as appropriate.
• Drives development and testing to assess performance against design specifications.
• Participate in Human Factors Engineering/Usability Engineering tasks and activities.
• Strong analytical and problem-solving skills.
• Establish interfaces across other organizational groups.
• Work independently to apply technical expertise to lead efforts in system design, implementation, integration, and verification and validation (V&V) of medical devices and products.
• Participate in requirements management activities involving creation, decomposition, and traceability of requirements.
• Prepare and deliver presentations of project results to others; present data to larger and more diverse audiences.
• Participate in the evaluation and assessment of competitive products, processes, and/or new trends.
• Engage with the Original Equipment Manufacturer (OEM) to provide technical oversight and guidance on evolution of the design.
• Collaborate with hardware, software, and reagent team members to develop and implement product designs.
• Ensure the necessary documentation for V&V activities are included in the project Design History File (DHF).
• Assist in the development of manufacturing processes and troubleshooting issues to determine root cause and possible engineering solutions.
• Collaborate with cross-functional teams to ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.
• Participate in product risk management activities involving system Hazard Analysis (HA) and Failure Modes and Effects Analysis (FMEA).
• Participate in project planning, process updates, design reviews, and contributes to experimental design.
• Utilize integration, analytical, and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system issues.
• Apply working knowledge of DOE, analysis and interpretation of test results, failure investigation, and root cause failure analysis.
• Uphold company mission and values through accountability, innovation, integrity, quality, Support and comply with the company’s Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work nights and/or weekends.
• Ability to lift up to 25 pounds for approximately 5% of a typical working day.
• Ability to work seated for approximately 75% of a typical working day.
• Ability to work standing for approximately 25% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to perform repetitious actions using lab tools and equipment.
• Ability and means to travel between Redwood City locations.
• Ability to travel 15% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor’s degree in Biology, Biochemistry, Systems Engineering, Biomedical Engineering, Physics, or related field.
• Authorization to work in the United States without sponsorship.
• 10+ years of relevant experience, including previous hands‑on involvement as an engineer, scientist, or product developer working through a formal phase gate or new product development process in the IVD medical device industry (e.g., System Integration Engineer, System Development Engineer, or related occupation).
• Solid technical writing skills to produce reports and documents; writes independently; evaluates the writing of others.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Experience with instrument automation or scientific instrumentation.
• Six Sigma certification.
• Design for Six Sigma (DFSS) experience.
• Proficiency with formal requirements management tools.
• Advanced degree (Masters / PhD) in Biology, Biochemistry, Systems Engineering, Biomedical Engineering, Physics, or related field.
• Experience with next generation sequencing, immuno‑histochemistry, in‑situ hybridization, PCR, methylation.
• Experience with system analysis, model‑based system engineering, and system architecture

The base pay for this position is $99,300.00 – $198,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Product Development DIVISION: ONCO Cancer Diagnostics LOCATION: United States > La Jolla : Torrey Pines Science Park ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

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