Senior Systems Engineer

Thornton Tomasetti; California; On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott Laboratories in Sylmar, CA is seeking a Senior Systems Engineer to lead systems engineering efforts on medical device programs, translating input requirements into defined system features, specifications and verification plans. You will collaborate with cross-functional teams to ensure compliant, timely delivery.

The role emphasizes working with clinical, regulatory, engineering and marketing functions, with travel around 5% and a base pay range of $90,000 to $180,000 annually.

Qualifications

• Requires a Bachelor's degree in Biomedical or Electrical Engineering or related field, or equivalent experience.
• Minimum 6 years in medical product development or similar setting, with cross-functional exposure.
• Strong ability to translate stakeholder input into system specifications and verification plans.

Responsibilities

• Lead systems engineering tasks for a program or major features.
• Define system specifications considering clinical and regulatory constraints.
• Develop verification plans, assess risks, and support cost/schedule planning.
• Collaborate with clinical, regulatory, and manufacturing teams to ensure compliant delivery.

Skills

Systems engineering

Medical device development

Cross-functional collaboration

Regulatory compliance

FDA regulations

Education

Bachelor's in Biomedical Engineering

Bachelor's in Electrical Engineering

Equivalent combination of education and work experience

Job description

## Senior Systems EngineerApply: United States - California - Sylmar: Full time: Posted Today: 31162156Abbott 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 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 yearsRelevant, 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 – $180,000.00In 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\\_Spanish.pdf