Primary Responsibilities

Leadership and Strategic Direction:

– Provide technical leadership and strategic guidance to the engineering team, aligning efforts with overall business objectives.

– Collaborate with cross-functional teams to formulate and execute the engineering roadmap, ensuring alignment with company goals.

Product Development Oversight:

– Supervise the entire product development lifecycle, ensuring compliance with regulatory requirements (FDA, ISO, etc.).

– Drive the creation of innovative medical devices, incorporating cutting-edge technologies and industry best practices.

Team Management:

– Cultivate, mentor, and lead a high-performing engineering team, fostering a culture of collaboration, innovation, and accountability.

– Offer guidance and support for the professional development and career growth of engineering team members.

Quality Assurance and Regulatory Compliance:

– Ensure that all engineering activities adhere to relevant regulatory standards and quality management systems.

– Collaborate with regulatory affairs to navigate and address regulatory challenges in the development process.

Technology Assessment and Adoption:

– Stay informed about emerging technologies and industry trends, evaluating their potential impact on product development.

– Lead the identification and adoption of new technologies to enhance product functionality and competitiveness.

Cross-functional Collaboration:

– Work closely with cross-functional teams, including marketing, operations, and quality assurance, to seamlessly integrate engineering efforts with overall business objectives.

Budget and Resource Management:

– Develop and manage the engineering budget, effectively allocating resources to meet project timelines and objectives.

Requirements (Education, Skills, and Experience)

– Preferred: Bachelor of Science in engineering or a related field.

– Minimum of 10 years of leadership experience, with at least 5 years in medical device engineering.

– Proven track record of successfully leading and delivering complex medical device projects from concept to commercialization.

– Strong knowledge of regulatory requirements for medical devices (FDA, ISO, etc.).

– Exceptional leadership and team management skills, emphasizing the development of high-performing teams.

– Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.