Role
Summary:
The Head of Product Engineering will oversee the design, development, and production of the Digital Analyser system, leading a multidisciplinary team across software, hardware, and firmware. The successful candidate will also manage key external relationships with contractors, suppliers, and clients. This is an exciting opportunity to make a significant impact on the healthcare industry while leading the integration of medical devices with cloud-based platforms, ensuring compliance with Software as a Medical Device (SaMD) standards.
Key Responsibilities:
1. Product Leadership: Manage the design, manufacture, and development of the Digital Analyser, collaborating closely with senior leadership to drive the company's growth and product success.
2. Software & Firmware Development: Oversee software, firmware, and hardware development, including the PC-based software coded in C# and AWS cloud-based systems, ensuring seamless interaction between components and further development of the cloud infrastructure.
3. Cloud Platform Integration: Lead efforts to integrate the Digital Analyser with cloud-based platforms, ensuring secure and efficient data transfer and working with middleware APIs to enable connectivity with healthcare systems, including NHS platforms.
4. Team & Contractor Management: Grow and lead the engineering team, including the immediate hire of a software engineer, while managing external contractors and overseeing project delivery.
5. Quality & Regulatory Compliance: Ensure adherence to medical device regulatory standards, preparing detailed technical documentation for market placement and product compliance.
6. Client & Stakeholder Collaboration: Work closely with internal teams and clients, incorporating feedback into product development to improve satisfaction and drive future innovations.
Qualifications & Experience Required:
7. Medical Device Expertise: Proven experience with medical devices or In Vitro Diagnostic (IVD) products, specifically within the Software as a Medical Device (SaMD) field.
8. Technical Leadership: Strong expertise in software and firmware development, cloud-based platform integration, and experience with AWS systems. Ability to troubleshoot software-firmware interactions and ensure smooth integration of components.
9. Leadership Skills: Demonstrated ability to lead cross-functional teams, manage contractors, and drive complex technical projects to completion. Experience hiring and mentoring engineers is a plus.
10. Regulatory Knowledge: Strong understanding of medical device regulations and technical documentation requirements.
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