MAIN RESPONSIBILITIES
Leads/owns pre-defined tasks within a larger effort such as definition, verification or product development of a sub-system, and drives them to on-time, high quality completion.
Investigates and defines system requirements for new algorithms, and facilitates the transition of algorithms into new projects through clinical review and evaluation. Assesses the clinical and system risks of new algorithms and features, and identifies potential interactions with existing ones. Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of new algorithms.
Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, and translates these into specific system requirements/interface specifications. Participates in broad cross functional review of work output. Updates and maintains feature specifications for one major project and may support one or more minor project.
Simulates or tests aspects of new projects or algorithms to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyzes electrograms, diagnostic or programming data collected from the field or from research studies. Defines and conducts storyboarding/beta testing to evaluate/measure customer acceptance of proposed product performance and operational characteristics. Analyzes and reports findings to immediate line management.
Investigates and defines systems engineering requirements for new algorithms or features, and facilitates the transition of algorithms into new projects through clinical review and evaluation.
Contributes to the evaluation and verification of a specific subsystem or project prior to submission.
Provides input into the development of system verification plans, and the conduct of those tests.
Develops, maintains, and executes automated test frameworks, scripts, and tools to improve test efficiency, coverage, and repeatability.
Interacts with functional groups as necessary to conduct feasibility studies, technology assessments, concept studies, or benchmarking studies.
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
Bachelors Degree (± 16 years): Biomedical Engineering or a related engineering field OR an equivalent combination of education and work experience
Masters Degree (± 18 years): In a relevant discipline/concentration, including Biomedical Engineering, preferred. With relevant project experience preferred.
Experience/Background: Minimum 2 years
Relevant, progressively more responsible work experience in medical product development.
Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. Medical device industry experience preferred.
Professional certification or designation preferred.
Experience with programming or scripting languages (such as C#, Python, MATLAB, C++, or similar) and the development of test automation tools, frameworks, or scripts for system verification and validation is 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 10%, including internationally.
- The base pay for this position is
- $81,500.00 – $141,300.00
- 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
No
MEDICAL SURVEILLANCE
No
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/External/EEO_Spanish.pdf
