About the role
The Engineering Manager will lead the engineering development effort for Fertilis to deliver a commercially successful product portfolio within a regulated industry. As the 2IC to the Chief Product Engineering Officer, they will be instrumental in building the engineering team and the engineering capability for Fertilis.
With their background in systems engineering and medical devices, they will lead the team in architecting and implementing the product solution that will meet the user needs, business drivers and regulatory requirements for Fertilis’ medical device.
• 10+ years experience in product design and development, with at least 5 years experience in electromechanical medical devices and sterile consumables
• Strong leadership skills with experience managing, delegating, and mentoring a multidisciplinary engineering team
• Strong technical leadership skills – this is a critical decision maker role for all engineering work and the technical aspects of the product portfolio
• Strong systems engineering skills and requirements management
• Thorough understanding of product development processes and Quality Management Systems, experience with ISO13485 and ISO14971 essential; IEC62366 and IEC62304 highly desirable