• 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:

• 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.