JOB DESCRIPTION:MAIN PURPOSE OF ROLEWorking under general supervision, supports product development efforts by performing systems engineering tasks such as investigating, defining, analyzing, documenting and testing activities associated with the development of specific projects. Performs additional analysis and/or interviews to determine the requirements and constraints on the assigned portion of the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Demonstrates aspects of technical or organizational leadership within the current projects. Has the ability to apply technical, clinical and marketing understanding of issues to bring tasks to resolution within assigned projects. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises appropriate level of technical judgment in planning, organizing, performing and coordinating systems engineering assignments. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes.
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.
QUALIFICATIONSEducation: - 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)
