• Understand key business objectives and strategy for the product, and be able to synthesize and communicate these objectives to the development team in terms of needed functionality.
• Identify product specifications and translate them into requirements and limitations that need to be communicated with stakeholders.
• Generate medical device development documentation according to certified ISO 13485 and IEC 62304 QMS procedures, involving relevant domains like security, safety, and privacy and be end responsible for QMS compliance.
• Provide architectural expertise, direction, and assistance to the software development teams
• Facilitate, prioritize, and decide which functionality will be developed.
• Respond to unforeseen conditions and setbacks and adapting the product architecture and development plan accordingly.
Knowledge and experience:
• More than 5 years of experience in engineering management and system architecting.
• Hands-on experience with requirements gathering/analysis.
• Strong knowledge of software development principles and practices.
• Extensive experience in Agile development methodologies.
• Proven project planning and management experience.
• Exceptional analytical, conceptual, and problem-solving abilities.
• Good written and verbal communication skills (fluent in English).
• Strong interpersonal and consultative skills.
• Ability to conduct research into emerging technologies and trends, standards, and products.
• Ability to present ideas in user-friendly language.
• Able to prioritize and execute tasks in a high-pressure environment.
• Experience working in a team-oriented, collaborative environment.