JOB DESCRIPTION:MAIN PURPOSE OF ROLEWorking under general supervision, performs specialized level systems engineering tasks such as investigating, defining, analyzing, documenting and testing activities associated with the development of new algorithms or the development of specific projects. Also performs additional analysis and/or interviews to determine the requirements and constraints of various portions 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.
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- Analyzes input requirements for medical devices, supports the instrumentation/service infrastructure, and translates these into specific system requirement/interface specifications.
- Participates in and contributes to the broad cross functional review of work output.
- Updates and maintains feature specifications in narrowly defined areas for specific projects.
- Simulates or tests aspects of new projects or algorithms to evaluate prototypes and verify 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 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.
- Interacts with functional groups as necessary to conduct feasibility studies, technology assessments, concept studies, or benchmarking studies.
- 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, Computer Science Engineering, Electronics Engineering, or related engineering field or an equivalent combination of education and work experience
Experience/Background- Minimum of 6 months in medical product development is required.
- Medical device industry experience 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 including internationally.
The base pay for this position is $73,900.00 - $116,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Product Development
DIVISION:CRM Cardiac Rhythm Management
LOCATION:United States > Sunnyvale : 645-647 Almanor Ave
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
