• Advanced degree in Biomedical Engineering, Engineering or another relevant technical field (Ph.D. preferred, M.Eng or M.Sc.. or equivalent required).
• 15+ years of experience in technical product development, plus 5+ years of experience in a management role as Head of Technology or CTO within the medical devices field.
• Strong technical background with a deep understanding of the medical device industry, including knowledge of in vitro diagnostics, preferably in lateral flow and microfluidics.
• Expertise in data analysis and familiarity with FDA regulations, EU IVDR, GMP, ISO 13485 and other applicable regulatory standards
• Proven track record of successfully delivering complex, high-impact projects on time and within budget.
• Experience leading and developing high-performing product management teams.
• Evidence of ability to proactive solve problems and think ahead about the long-term needs of a growing business.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively with cross-functional teams and senior stakeholders.