Software Test Manager

Description:

Cure Talent is thrilled to partner with an innovative MedTech startup at the forefront of wearable medical device development and innovation.

Due to continued growth, we have an exciting opportunity for a Software Test Manager / Development Manager (remote role) to take responsibility for software product development (SaMD) deployed on mobile applications (iOS and Android) and support the wider business software solutions.

The role has a strong focus on software Quality Assurance (QA), testing, validation/verification, software documentation/regulation and software cloud operations.

Key Responsibilities:

* Develop, launch, and maintain high-quality, complaint and secure iOS and Android mobile medical device applications on App Stores through external development team.

* Work closely with contracted software development teams to deliver new products, providing direction and management to projects.

* Ensuring high quality and timely delivery of software releases.

* Support Microsoft Azure cloud databases and applications.

* Take a lead role building company software development capabilities and IT processes.

Qualifications and Skills:

* Have a track record of delivering medical device, digital health Apps deployed on mobile devices which are used to control other medical devices.

* Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366.

* Deep understanding of software development lifecycle (SDLC) and best practices in the medical device Industry.

* Familiarity with UK/EU and US data protection regulations and experience in cybersecurity standards for health software and IT systems.

You will not be writing code in this role; it’s very much the management of the software development lifecycle through the various third parties and consultancies as the technical SME