Costa Rica-Heredia
About the role:
We are looking for a Systems Engineer to become a member of a dynamic team that provides technical leadership with a mix of mechanical, electrical, software, and catheter engineers and an interdisciplinary team of Marketing, Regulatory, and Quality. This individual will work on new projects from concept to commercialization and projects that maintain our currently released mapping system. The individual will be responsible for defining, analyzing and implementing system requirements, risk analysis, and usability as well as provide input to cross-functional deliverables.
Key Responsibilities:
- Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies.
- Solve system problems by analyzing the situation and recommending corrective or alternative actions.
- Documents system architecture and design control elements by writing documents, reports, and memos.
- Collaborates in the translation of customer needs into technical requirements, engaging the field, marketing, service and other functions as needed.
- Provides expertise and conducts evaluation of validation and verification activities.
- Assist with industry-based standards testing for safety and EMC according to 60601-1
- Supports the risk analysis for the project.
- Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.
Minumum Qualifications:
- Bachelor degree in Engineering (EE, computer science, biomedical or mechanical) and related field.
- 3-5 Years of experience within the Medical Device industry with BS degree, 0-3 Years with MS or PhD
- Experience with technologies for image-guided minimally invasive procedures.
- Demonstrated understanding of medical image generation and processing, such as intracardiac echo.
- Strong communications and time management abilities.
- Ability to provide technical leadership within cross-functional teams.
- Track record of independent and solution-oriented work style.
Preferred Qualifications:
- Medical Device experience working with imaging and signal processing systems (EEG, Electrophysiology, etc.).
- Experience conducting simulations, mathematical analysis and/or system interaction analysis.
- At least 2 years of engineering experience in mixed HW/SW systems.
- Technical experience with digital and analog low noise systems.
- Usability engineering experience.
- Experience with IEC 62304