Chief Technology Officer (Client) ID: Matrix Medical Devices

Unclassified - Cleveland, OH

Full-time - Senior

Cleveland, OH

About the position

Matrix Medical Devices is seeking a Chief Technology Officer (CTO) for a full-time onsite position in Cleveland, OH. The CTO will play a pivotal role in the organization, focusing on the planning and management of new product development programs specifically for Over-the-Counter (OTC) Medical Devices. This position requires a deep understanding of the regulatory landscape, particularly compliance with US FDA regulations and international standards. The CTO will be responsible for ensuring that all product development initiatives align with applicable regulations, including US FDA 21 CFR 820 and ISO 13485:2016, while also adhering to industry best practices. In this role, the CTO will lead a team of professionals, fostering an environment of innovation and collaboration. The successful candidate will have a strong background in medical device product development, with a proven track record of managing projects from conception through to market launch. This includes overseeing the entire product lifecycle, from initial concept and design to regulatory approval and commercialization. The CTO will also be responsible for budget planning and management, ensuring that all projects are delivered on time and within budget. The ideal candidate will possess excellent problem-solving and decision-making abilities, along with strong leadership skills to effectively manage and motivate a diverse team. Communication and interpersonal skills are crucial, as the CTO will be required to liaise with various stakeholders, including regulatory bodies, internal teams, and external partners. A bachelor's degree in Engineering or a related field is required, with an advanced degree preferred. Additionally, statistical knowledge will be beneficial in analyzing data and making informed decisions regarding product development.

Responsibilities

• Plan and manage new product development programs for OTC Medical Devices.
• Ensure compliance with US FDA regulations and ISO standards.
• Oversee the entire product lifecycle from concept to market launch.
• Manage project budgets and timelines effectively.
• Lead and mentor a team of professionals in product development.
• Collaborate with regulatory bodies and internal teams to ensure compliance and quality standards are met.
• Conduct due diligence and manage intellectual property matters.

Requirements

• 12 - 15 years of experience in medical device product development.
• Experience with US FDA 21 CFR 820 and ISO 13485:2016 compliance.
• Strong project management and strategic planning skills.
• Experience with Quality Management Systems.
• Proven leadership skills and team management experience.
• Budget planning and management expertise.
• Excellent problem-solving and decision-making abilities.
• Strong communication and interpersonal skills.
• Bachelor's degree in Engineering or a related field; advanced degree preferred.
• Statistical knowledge.