R&D Engineer
Katalyst Healthcares & Life Sciences | Orlando | www.resume-library.com |
Responsibilities:
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 IEC(phone number removed) Safety standard
In depth knowledge in developing and testing products to IEC62336 EMC standard
Requirements:
BS degree in engineering
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.
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 IEC(phone number removed) Safety standard
In depth knowledge in developing and testing products to IEC62336 EMC standard
Requirements:
BS degree in engineering
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.
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