Device Project Manager

Major duties and responsibilities:
• Actively participate in aspects of design and development activities for an electromechanical class IIb part of a drug-delivery system.
• Close management of the subcontractor that develops the part – both from technical point of view and management/ alignment.
• Ensure the development process meets the design controls and is carried according to the company’s quality system.  
• Sync internal team with the development status, and actively involve mechanical, electrical, SW teams as necessary in decision points.
• Ensure integration is conducted smoothly with other development functions/disciplines.
• Lead Design Reviews for the product and ensure system design requirements are met.
• Establish requirements and specifications, including justification and supportive testing.
• Support test method definition and success criteria determination.
• Identify and report technical and project risks.
 
Education and Knowledge Requirements:
• Eng. degree or in Electronics or a science related field
• Al least 5 years of experience leading technical projects in medical device – electronics/HW/system engineering.
• Demonstrated experience developing departmental strategies and processes.
• Strong technical orientation.
• Solid understanding of FDA and international regulations.
• Excellent communication skills with ability to deal effectively with all levels of management and ability to interface with other functional areas to ensure process and priorities are aligned.