Staff Engineer, Systems Integration

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

Job summary

Abbott Laboratories in the United States seeks a Staff Engineer, Systems Engineering to lead system integration for cross-functional IVD medical device programs from concept through manufacturing. You will influence design reviews, V&V, DOE, and system architectures across multiple technologies and product lines.

You will collaborate with hardware, software, and reagent teams, manage requirements traceability, and present project results to diverse audiences while ensuring compliance with

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 involvement as an engineer, scientist, or product developer in IVD medical devices.
• Solid technical writing skills to produce reports and documents; writes independently; evaluates others' writing.
• Demonstrated ability to perform essential duties with or without accommodation.

Responsibilities

• Assess design feasibility and test product functionality.
• Lead V&V activities at the system level.
• Maintain traceability of requirements to design outputs.
• Participate in new product design and improvements.
• Define and create system architectures and documentation trees.
• Lead system integration during design and V&V phases.
• Utilize DOE for experiments and decision making.
• Support manufacturing processes and troubleshooting.
• Ensure DHF documentation and regulatory compliance.

Skills

System integration

V&V leadership

Design of Experiment

Technical writing

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's degree

Six Sigma certification

Master's/PhD preferred

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 andproducts.
• Participate in requirements management activities involving creation, decomposition, andtraceability of requirements.
• Prepare and deliver presentations of project results to others; present data to larger andmore diverse audiences.
• Participate in the evaluation and assessment of competitive products, processes, and/ornew trends.
• Engage with the Original Equipment Manufacturer (OEM) to provide technical oversight andguidance on evolution of the design.
• Collaborate with hardware, software, and reagent team members to develop and implementproduct designs.
• Ensure the necessary documentation for V&V activities are included in the project DesignHistory File (DHF).
• Assist in the development of manufacturing processes and troubleshooting issues todetermine root cause and possible engineering solutions.
• Collaborate with cross-functional teams to ensure all development activities are conductedin adherence to applicable national/international regulations, guidelines, company policies,SOPs, and industry standards.
• Participate in product risk management activities involving system Hazard Analysis (HA) andFailure Modes and Effects Analysis (FMEA).
• Participate in project planning, process updates, design reviews, and contributes toexperimental design.
• Utilize integration, analytical, and troubleshooting skills to understand system interfaces andbe able to quickly analyze, troubleshoot, and resolve system issues.
• Apply working knowledge of DOE, analysis and interpretation of test results, failureinvestigation, 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 andprocedures.
• 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 workstanding 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 productdevelopment 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 withoutaccommodation.

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.