System Engineer- Medical

System Engineer
Orlando, FL (Onsite)
Contract
Must Have: Medical Device, ISO 14971, IEC60601-1 Safety standard, IEC62336 EMC standard, DOORS
Systems Engineering in the medical area is what is needed and experience with these specs:

• 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 and reviewing requirements.

To succeed in this role, you should have the following skills and experience:

• 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

Preferred 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