Staff Systems Engineer

Abbott (abbottcareers2 board); United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Abbott is seeking a senior systems engineer to lead programs and manage complex, novel integrations across disciplines. You will organize work, define behaviors, verify designs, and ensure product quality while balancing schedule and cost constraints.

You will serve as SME for designated systems, collaborate with cross-functional teams including Clinical, Regulatory, and Engineering, and drive verification, validation, and design control activities in line with FDA and ISO requirements.

Qualifications

• Minimum 8 years progressively more responsible system engineering with product development experience.
• Experience with electrical, electro-mechanical, software or biomedical technologies relevant to implantable systems.
• Strong knowledge of ISO and FDA design controls and regulatory requirements.

Responsibilities

• Leads programs with novelty and cross-disciplinary integration across teams.
• Plans, frames problems, designs solutions, and verifies outputs within schedule and cost constraints.
• Organizes work to deliver programs and guides the execution of assigned tasks.
• Contributes as SME for designated systems and engages in broad cross-functional reviews.

Skills

Systems engineering

Cross-functional collaboration

Requirements analysis

Education

Bachelor's degree in Software Engineering or Computer Science

Master's degree in Biomedical Engineering or related discipline

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.

MAIN PURPOSE OF ROLE

Accountable for delivering entire programs or complex, significant portions of programs with some level of novelty. Also accountable for organizing and managing work, investigating issues, defining behaviors, leading others in the executing of work, applying expertise and verifying designs and products for systems. Accountable for applying an expert understanding of applications, customer needs to be addressed, behaviors and architected solutions to streamline product development in addition to ensuring product quality. Ensures the logical and systematic conversion of customer requirements and performance requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Primarily supports one key major program, but may advise other multiple efforts.

MAIN RESPONSIBILITIES

• Leads programs while exercising significant novelty and integration across various disciplines as well as team members. Applies a demonstrated portfolio-centric approach to developing programs which are incorporated into platform strategies that achieve "win/win" scenarios for assigned efforts and platforms.
• Plans and executes the department strategy to deliver upon responsibilities; gathers information, frames problems, devises/executes plans, tracks progress, and adjusts/measures success within scope of responsibility to improve development efforts as well as the organization. Applies skills to planning product development work; capturing requirements, designing solutions, defining behaviors, investigating issues, evaluating trade-offs, and verifying output.
• Organizes and manages work to deliver programs, leads in the execution of assigned work. Prioritizes tasks by distinguishing urgent from important tasks and assess cost/benefit trade-offs.
• Design and conduct system level characterization/verification of complex systems; collect, organize, analyze, and document test results.
• Develops and applies an expert understand of designated systems as well as serves as a subject matter expert for the development team regarding behaviors, implementation trade-offs, customer needs, satisfaction of customer needs, clinical applications, and the applicable technologies required to solve problems and deliver upon business objectives. Participates in broad cross-functional reviews of work output.
• Fosters collaboration with cross-functional teams, platform architects and other leaders to drive work to completion and resolve issues. Successfully influences stakeholders. Communicates effectively with cross-functional teams and senior management. Keeps leadership informed of progress and issues.
• Innovates within program work to improve the organization, solve technical challenges, and develop intellectual property.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

QUALIFICATIONS

Education

Education Level

Major/Field of Study

Or

Education Level

• Bachelors Degree (± 16 years) Software engineering, computer science, or a related engineering field. an equivalent combination of education and work experience
• Masters Degree (± 18 years) Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred.

Experience/Background

Experience

Experience Details

Minimum 8 years

Progressively more responsible work experience system engineering with product development experience in Engineering or physical science.

Experienced in one or more of the following: electrical, electro-mechanical, software, mathematical, chemical or biomedical technologies as they pertain to the design, integration, evaluation and commercialization of implantable systems.

Demonstrated ability to apply an expert understanding of systems to issues in order to bring tasks to resolution within assigned projects.

Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required.

Strong knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements.

Domain knowledge of cardiac rhythm management (CRM) devic