Key Responsibilities
* Lead and manage the entire lifecycle of R&D projects, from initial concept development through design, verification, validation, and commercialization.
* Develop detailed project plans, timelines, budgets, and resource allocation strategies, ensuring alignment with company goals.
* Coordinate cross-functional teams, including engineering, quality assurance, regulatory affairs, clinical research, and marketing.
* Identify potential project risks and develop mitigation strategies to ensure project milestones are achieved on time and within budget.
* Act as the primary point of contact for project stakeholders, providing regular updates on progress, challenges, and solutions.
* Ensure compliance with ISO 13485, MDR (Medical Device Regulation), FDA guidelines, and other relevant standards.
* Drive innovation by collaborating closely with the R&D team to explore new technologies and solutions for surgical navigation.
* Facilitate the preparation of technical documentation, risk analyses, and design control processes.
Required Qualifications
* Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field. A background in medical device technology is mandatory
* Proven experience (5+ years min.) in managing complex R&D projects within the Medtech or healthcare sector.
* Strong knowledge of medical device development processes, including design control and regulatory requirements.
* Excellent project management skills, with experience using methodologies such as Agile or Stage-Gate.
* Strong leadership, communication, and interpersonal skills.
* Proficiency in English and German