System Engineer - Katalyst Healthcares & Life Sciences
Orlando, FL 32789
About the Job
Responsibilities:
- In depth knowledge performing risk management per ISO 14971
- In depth knowledge in developing and testing products to IEC60601-1 Safety standard.
- In depth knowledge in developing and testing products to IEC62336 EMC standard
- Experience with deriving and simulating human interactions with devices and device use conditions.
- Experience with electronic requirement data management SW preferably DOORS
- Minimum five years engineering / R&D experience in a rigorous quality-focused environment.
- DOORS and experience writing, reviewing requirements.
- Overall technical leadership and responsibility for realization of a new product release and sustaining activity.
- Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
- Systems design/architecture and Integration oversight.
- Support for NPI efforts that create value for Clinical Applications and Devices Organization through innovation and design, while delivering high quality engineering solutions.
- Technical liaison to the program.
- Defect/Risk management and Design Reviews.
- A team of highly skilled engineers that is focused on creating world class health care solutions.
- Our focus on improving lives contributes to our amazing work environment and culture.
- BS degree in engineering.
- Experience leading medical, or other regulated industry, product development.
- Experience in leading groups to solutions for complex problems.
- Experience with deriving and simulating human interactions with devices and device use conditions.
- Experience with electronic requirement data management SW preferably DOORS.
- Minimum five years engineering / R&D experience in a rigorous quality-focused environment.
- Minimum three years' experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines.
- Excellent requirements and specification writing skills.
- Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product.
- Ability to build and maintain effective cross-functional and cross-organizational relationships.
- Excellent oral, written and presentation skills.
- In depth knowledge performing risk management per ISO 14971
- In depth knowledge in developing and testing products to IEC60601-1 Safety standard.
- In depth knowledge in developing and testing products to IEC62336 EMC standard.
Source : Katalyst Healthcares & Life Sciences
