Systems Engineer-Medical Domain

Katalyst Healthcares & Life Sciences

Orlando, FL

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JOB DETAILS

SKILLS

Architectural Design, Best Practices, Bug Tracking/Defect Management, Clinical Information Systems, Computer Firmware, Cross-Functional, Data Management, Electricity, Human Interaction, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Leadership, Medical Equipment, Presentation/Verbal Skills, Product Development, Product Testing, Product/Service Launch, Quality Assurance Methodology, Quality Engineering, Regulatory Requirements, Requirements Derivation, Requirements Management, Requirements Management Software, Research & Development (R&D), Risk Management, Safety Standards, Software Development, System Architecture, Systems Engineering, Team Lead/Manager, Technical Leadership, Test Plan/Schedule, Testing, Validation Testing, Writing Skills

LOCATION

Orlando, FL

POSTED

30+ days ago

Job Summary:

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.

Responsilities:

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.

Requirements:

Understanding of US and international regulatory requirements for medical devices strongly preferred.
Experience developing reliability plans.
Knowledge of product development processes and best practices.
Knowledge of verification and validation testing processes.
Electrical or Software development experience is a plus.
Master's degree preferred.

Systems Engineer-Medical Domain

Katalyst Healthcares & Life Sciences

Orlando, FL

About the Company

Katalyst Healthcares & Life Sciences

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