Overall technical leadership and responsibility for realization of a new product release and sustaining activity.

Requirements

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

Overall technical leadership and responsibility for realization of a new product release and sustaining activity.

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

System Engineer