Does working at the forefront of Medical Technology excite you? Do you have an interest in AI and Augmented Reality? Are you looking to lead an already well established and developed team?

Are you an experienced Software Lead/Manager with proven Medical Device experience? Have you gone through Multiple design cycles with complex systems? Do you have knowledge of IEC 62304?

If so, we are working with an innovator in Medical Imaging and VR technology, who's game changing system is sending waves through MedTech.

The Role:

• Lead and manage a team of Software and Systems Engineers.
• Represent the software function in project teams and ensure alignment.
• Drive Agile processes and foster a collaborative team environment.
• Mentor team members in software and medical device development.
• Oversee the software development lifecycle, including planning, requirements, verification, and documentation.
• Collaborate with regulatory and development teams to implement and follow Design Controls.
• Participate in risk management and support regulatory submissions and audits.
• Maintain and update software development SOPs.
• Contribute hands-on to user stories, design discussions, and code reviews.
• Coordinate project scope, activities, and resource allocation with the project team.
• Support additional tasks to achieve company goals.

The Person:

• Proven experience leading software teams through the full development lifecycle.
• Expertise in medical device software development and compliance with IEC 62304, FDA QMS, and ISO 13485.
• Strong background in software development, including C# and C++, with prior leadership roles.
• Agile development experience, including sprint planning and Scrum.
• Ability to work effectively with distributed teams.

Qualifications:

• Bachelor’s degree in Computer Science, Computer Engineering, Software Engineering, or related field.
• Strong communication skills for interacting with technical and business stakeholders.
• Proficiency in Microsoft Office and desktop operating systems.
• Bonus skills: Medical imaging, DICOM, PACS, Unity/3D graphics, AR/VR, or software cybersecurity (FDA guidelines).