Senior Systems Engineer

Abbott; United States; On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott is seeking a systems engineering lead to support product development across medical devices. You will gather requirements, define system features, and align technical work with regulatory and clinical priorities.

The role involves planning, testing, and guiding teams through complex, multi-disciplinary projects within a fast-paced environment. With a base salary range highlighted, the position requires deep expertise in medical device development, regulatory standards, and strong

Qualifications

• Bachelor's degree in Biomedical Engineering, Electrical Engineering, or related field.
• Minimum 6 years of relevant experience in medical product development.
• Strong ability to integrate clinical, engineering, marketing and regulatory inputs.

Responsibilities

• Lead systems engineering tasks to define or validate a program or features.
• Define system specifications considering technical and regulatory constraints.
• Assist in determining clinical priorities for new products.
• Plan and evaluate performance, analyze system integration, and assess risks and costs.
• Provide guidance to teams and lead cross-functional execution.
• Test prototypes and validate outputs against intended use requirements.
• Contribute to system verification plans and test conduct.

Skills

Systems engineering

Requirements analysis

Project leadership

Regulatory knowledge

Testing and validation

Cross-functional collaboration

Education

Bachelor's degree in Biomedical or Electrical Engineering

Tools

Regulatory documentation

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:

Support product development efforts as a key member of program teams by leading systems engineering tasks defining, developing or validating a smaller program or several features on a major program.

MAIN RESPONSIBILITIES

• Gathers, understands, and analyzes input requirements from stakeholders for new medical devices while supporting the instrumentation/service infrastructure. Translates information into specific system features.
• Synthesizes all gathered information together with technical and regulatory constraints in order to define a system and its behavior resulting in defining a system specification.
• Assists in determining clinical priorities for new products.
• Performs technical planning and performance evaluation studies, conducts technology assessment activities, analyzes system integration issues, generates initial baseline interface specifications, estimates costs and risk, and evaluates customer satisfaction through testing (alpha and beta), analysis and studies.
• Assign projects to specific teams and determine how systems will be architected and implemented. Provides guidance and leadership to teams as appropriate.
• Evaluates prototypes formally and informally through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirements.
• Provides input into the development of system verification plans and the conduct of those tests.
• Identifies and resolves issues, escalating as appropriate.
• 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

Education Level

Major/Field of Study

Or

Education Level

Bachelors Degree (± 16 years)

Biomedical Engineering, Electrical Engineering, a related engineering field, or equivalent, including relevant coursework and/or work experience in product development.

an equivalent combination of education and work experience

Experience/Background

Experience Details

Minimum 6 years

Relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience.

Demonstrated ability to apply an expert understanding of clinical application 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. Medical device industry experience preferred. Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred. Professional certification or designation preferred. Training and experience in manufacturing processes and methods preferred.

Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

Ability to travel approximately 5%, including internationally.

The base pay for this position is $90,000.00 - $180,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Product Development

DIVISION: CRM Cardiac Rhythm Management

LOCATION: United States > Sylmar : 13150 Telfair Avenue

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 5 % of the Time

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

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/Ext