Staff Systems Engineer
Staff Systems Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Opportunity:
The engineer will be primarily working on the heart failure device portfolio which remotely monitors changes in pulmonary artery (PA) pressure an early indicator of the onset of worsening heart failure to aid physicians in preventing worsening heart failure lower heart failure mortality rates and improve quality of life for our heart failure patients. The role is responsible for driving systems engineering for a wide range of Heart Failure device products including implantable sensors external reader systems used by clinicians and patients mobile application software and cloudbased web applications. This person will help to drive and lead the development of new programs and next generation products including system design and architecture requirements definition and management design documentation and system testing verification and validation.
Responsibilities:
- Lead product definition system architecture requirements writing requirements management requirements analysis risk analysis System V&V and design control documentation from design conception to launch.
- Participate in and drive systems level decision making accounting for and prioritizing critical needs and requirements and assessing various options and solutions.
- Gather assess and analyze needs and input from stakeholders and translates to system architecture definition and requirements.
- Lead the planning of system engineering tasks including timelines budgets and prioritization.
- Perform system level characterization of devices through development to refine requirements and finalize the design for System V&V.
- Collect organize analyze document and present results.
- Plan execute and/or lead System V&V testing data analysis and documentation.
- Communicate effectively to crossfunctional teams and senior management.
- Comply with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments.
RequiredQualifications:
- Bachlers Degree in Engineering (Mechanical Computer Electrical or Software) Computer Science or a related discipline
- 8 years of in a similar position including systems engineering and integration experience (integrating all system components electrical mechanical software) system architecture requirement/user need gathering endtoend (ideation to commercialization) technical product development experience and/or systemlevel verification
Preferred Qualifications:
- Advanced Degree in Engineering (Mechanical Computer Electrical or Software) Computer Science or related discipline
- Experience and expertise with systems consisting of hardware software mobile apps and cloud components
- Experience and expertise with systems with RF electromagnetics ASICs Bluetooth and NFC technologies
- Class III implantable medical device experience specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow pressure EKG etc)
- Strong knowledge of a development process consistent with ISO FDA design control standards or requirements and risk management practices.
- Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine Engineering Marketing and Regulatory Affairs
- Ability to work within a team and as an individual contributor and leader in a fastpaced changing environment
Required Experience:
Senior IC
Employment Type
Full-Time
