R&D Systems Engineer
This R&D Engineer will be part of the Electronic Medical Equipment (EME) Systems and Human Factors Engineering team and will focus primarily on integration of EME products within the Peripheral Interventions business. Project focus will include a variety of EME used for cryoablation of tissue and thrombolytic therapies. Day-to-day work will include a variety of activities such as system design, hands-on lab work, data analysis, documentation, task planning and coordination, and collaboration with others. A strong systems engineering and medical device aptitude is desired.
Key Responsibilities:
- Work with all stakeholders as appropriate to translate user needs into design requirements (e.g. hardware, software, mechanical, electrical, interface, etc.) consisting of system requirements, sub-system requirements, product/system security requirements, digital architecture (including cloud, on-premise (i.e. hospital network), IoT), and system interface requirements to define the system as a whole and all associated sub-systems.
- Design, define, and implement system requirements to generate design inputs/outputs, associated processes and working parameters by using current systems engineering methods and technologies. May include simulations, mathematical analysis and/or system interaction analysis.
- Collaborate with Quality Engineering, Design Assurance (DQA) and technical writing staff to produce final product technical document release (and associated risk management documentation) and the Design History File.
- Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, preparation of specifications, process capability studies, report preparation, and planning/coordination of work.
- Works independently to plan and schedule own activities necessary to meet timelines.
- Designs and coordinates standard engineering tests and experiments.
- Summarizes, analyzes, and draws conclusions from test results.
- Prepares standard reports/documentation to communicate results to technical community.
- Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
- Consults and solicits feedback from internal stakeholders to identify customer needs and translate these requirements into the device designs. In addition, provides support regarding product development to internal departments as it relates to device systems design.
Qualifications:
- Degree in BS Engineering (preference in Electrical, Computer, Software, or Biomedical)
- 3+ years of engineering work experience from a regulated industry.
- Highly self-motivated and directed.
- Proven analytical and problem-solving abilities.
- Proficient in requirements management tools.