o PhD, Masters or Bachelor of Engineering in Computer science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field.
o A minimum of three years of practical experience in both medical device product development and project management is required.
o Hands on experience in overseeing medical device projects that comply with HAS or FDA or MDR regulatory submission requirements.
o Proficiency in compiling documentation for medical device product development, such as Design History Files and Risk management Files.
o Familiarity with relevant standards and regulations in the medical device field, such as ISO 13485, IEC 62304, and ISO 14971.
o Proven track record in effectively managing external collaborators and/or contract manufacturers.
o Experience in managing projects involving software development for medical devices, Machine Learning projects, or Software as a Medical Device (SaMD) projects are desirable but not obligatory.
o Proficient in project management.
o Familiar with software development using agile methodologies.
o Familiar with machine learning is desirable but not obligatory.
o Possess good communication skills.
o Possess excellent teamwork and collaboration skills.
Abilities / Aptitudes:
o Possess advanced problem solving and analytical skills
o Plan and execute Software as a Medical Device (SaMD) projects, including AI applied to healthcare.
o Collaborate with researchers, clinicians, and industry partners to conceptualize and define projects aimed at developing novel, clinically relevant, and commercially viable software as medical device products.
o Lead a technical team in the product development, design verification, and validation of medical devices, including software as a medical device.
o Prepare design and development documentation by working together with software developers, quality, and regulatory personnel.
o Manage external collaborators, clinicians, quality and regulatory consultants, and contract manufacturers.
o Prepare project agreements, procurement specifications, and technical documents.
o Compile and communicate project progress reports for regular project reviews and milestone assessments with management and external parties.
o Establish and develop collaborations and licensing agreements with industry and strategic partners, including scoping out projects, evaluating potential collaborators for their clinical utility and technical and business viability, understanding, and negotiating IP terms for each project.