
Staff Systems Engineer
- Atlanta, GA
- $97,300-194,700 per year
- Permanent
- Full-time
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement, the
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
- 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 and drive systems level decision making, accounting for and prioritizing critical needs and requirements and assessing against various options and solutions.
- Gather, assess, and analyze needs and inputs 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 cross-functional 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.
- Bachler’s Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or 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, end-to-end (ideation to commercialization) technical product development experience, and/or system-level verification
- Advanced Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline
- Experience and expertise with systems consisting of hardware, software, mobile app, 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 fast-paced, changing environment