Software & Firmware Development Team, Medical Device Summary Our client, a medical device company specializing in robotic prosthetics, is seeking a U.S.-based software and firmware development team to assume ownership of an existing software platform and support the transition of development activities from a third-party organization to a new team. The ideal partner will have an established team capable of managing software development, maintenance, documentation, and knowledge transfer activities while operating within a regulated medical device environment. This team should possess deep expertise in medical device software development, mobile applications, cloud infrastructure, firmware, and regulatory compliance.
Job Duties
Taking ownership of an existing software platform and related development activities.
Supporting knowledge transfer from the current development organization.
Managing ongoing software and firmware development efforts.
Reviewing and maintaining software documentation.
Establishing compliant development processes and best practices.
Supporting long-term product development and maintenance activities.
Collaborating with internal engineering, quality, and regulatory teams.
Mandatory Requirements
Team must have demonstrated experience developing and maintaining software for FDA-regulated medical devices.
Strong expertise in Android, iOS, firmware/embedded software, backend development, cloud architecture (AWS preferred), and systems/software architecture.
Proven experience taking over existing software platforms, performing knowledge transfer, and transitioning development ownership from another organization.
Deep understanding of medical device regulations and quality standards, including ISO 13485, IEC 62304, Design Controls, software lifecycle documentation, risk management, and verification & validation activities.
Ability to review, audit, remediate, and maintain compliant software documentation.
Experience working within Agile development environments.
Preferred Requirements
Robotics, robotic prosthetics, digital health, connected device, or Software as a Medical Device (SaMD) experience.
Flutter development expertise.
Experience supporting global regulatory requirements and international markets.
Proven history of providing established teams that have successfully worked together on previous medical device development projects.