Staff Engineer, Systems Integration

Abbott•La Jolla, CA

15h•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.