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 :
- 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.
- 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.
- 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.
- 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.
- Quality & Regulatory Compliance : Ensure adherence to medical device regulatory standards, preparing detailed technical documentation for market placement and product compliance.
- 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 :
- Medical Device Expertise : Proven experience with medical devices or In Vitro Diagnostic (IVD) products, specifically within the Software as a Medical Device (SaMD) field.
- 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.
- 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.
- Regulatory Knowledge : Strong understanding of medical device regulations and technical documentation requirements.