Job Purpose (Role Definition):
This is a pivotal role within our R&D department, to lead the development of cutting-edge software and electronics products for safety-critical medical devices, reporting directly to the Head of Research & Innovation and will oversee the entire project lifecycle, from concept to commercialization.
Main Duties and Responsibilities:
Project Leadership : Lead cross-functional teams, including engineers, designers, and regulatory specialists, to deliver projects on time and within budget.
Technical Expertise : Possess a deep understanding of software and electronics development methodologies, particularly in the medical device industry.
Regulatory Compliance : Ensure all projects adhere to stringent regulatory standards (e.g., ISO 13485, IEC 62304) and quality management systems.
Project Risk Management : Identify, assess, and mitigate project risks, ensuring the safety and efficacy of our medical devices.
Stakeholder Management : Effectively communicate with stakeholders, including senior management, clinical teams, and regulatory authorities.
Technical Documentation : Oversee the creation and maintenance of comprehensive technical documentation, including design specifications, test plans, and validation reports.
Change Management : Oversee Change Control processes within design projects, conducting impact analyses, and prioritizing modifications to maintain quality and compliance.
Work Item Tracking : Monitor progress of project tasks, ensuring dependencies, relationships, and deliverables are well-managed.
Management Responsibilities:
None
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