Abbott Senior Systems Engineer in San Diego, California
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. A global leader in rapid point-of-care diagnostics, our products, as well as our new product development efforts, focus on infectious disease, cardiometabolic disease and toxicology.
The position of Principal System Engineer is within our Abbott Rapid Diagnostics division located at Alere San Diego in San Diego, California. This role will lead requirements analysis, traceability, hazard analysis and risk management activities for our next generation of portable diagnostics platforms product software in one or more projects.
This job description will be reviewed periodically and is subject to change by management.
Gather needs from different stakeholders and translate them into a system design and system requirements.
· Identify system and subsystem level interfaces and document these into interface protocol requirements.
· Create and maintain system traceability among needs, system, sub-system level requirements and risk management artifacts to ensure completeness and fully traceable design history file.
· Responsible for some or all of the following deliverables:
o Requirements Management Plan
o Requirements Analysis, User Needs, System Requirements, Subsystem Requirements
o Risk Management Plan
o Risk Analysis, Evaluation and Control, Preliminary Hazard Analysis, Device Hazard Analysis, Fault Tree Analysis, FMEA
o Risk Management Reports
· Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Responsible for exhibitingprofessional behavior with both internal/external business associates thatreflects positively on the company and is consistent with the company’spolicies and practices; build productive internal/external workingrelationships
Carries out duties incompliance with established business policies
· Other duties as assigned, according to the changing needs of the business
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
Bachelor of Science (M.S. preferred) in Biomedical Engineering,Electrical Engineering, or equivalent, including relevant courseworkand/or work experience in product development.
5+ years of experience in product development (comprisingelectro-mechanical and software pieces).
Proficient with Medical Device regulations (IEC 62304, 21 CFR part820.30-Design Controls).
Expert level requirement elicitation, analysis and documentationskills.
Ability to moderate requirements engineering discussions and workas a bridge among different engineering departments and globalstakeholders.
Experience architecting and allocating requirements across multiplesubsystems.
Experience with Preliminary Hazard Analysis (PHA), Fault TreeAnalysis (FTA) and Failure Mode and Effect Analysis (FMEA).
Experience setting up, configuring and using enterpriserequirements management systems (e.g.: Jama, IBM DOORs, Polarion) is aplus.
Strong written, verbal, interpersonal and presentation skills.
· Familiarity with Human Factors and Usability Engineering standards and guidelines (AAMI/ANSI HE75, ISO/IEC 62366, UCM 259760).
· Experience writing Use cases, creating Storyboards and using Voice-of-Customer (VOC) techniques to facilitate requirements gathering efforts (Interviews, Surveys, KJ Analysis, CTQ, AHP, Kano Analysis, and Critical Parameter management).
· Sets stretch goals and links them to strategic outcomes and business deliverables.
· Continually develops his/her own skillset.
An equal opportunityemployer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com