Corporate Overview:
Back pain affects 50 million Americans and is the number one cause of disability in the US with a societal cost of approximately $560 billion annually. There are also over 100 million opioid prescriptions written annually, highlighting the underlying need for improved pain management solutions. While the approximately 80,000 annual Spinal Cord Stimulation (SCS) implants was a $2.5B market in 2019 and growing (8% to 10% CAGR for the prior five years), the market is ripe for disruption. Additionally, SCS devices and procedures have favorable reimbursement with existing codes in place for physicians and facilities (hospitals and ASCs).
Founded in 2017, Presidio Medical is a well-financed, clinical stage, medical device company with a transformational neuromodulation platform technology. The company is based in South San Francisco and is growing rapidly. The company’s first indication is in chronic pain. Due to the proprietary stimulation compatibilities, Presidio Medical’s technology is targeting a significant unmet pain segment which can unlock and potentially double the addressable market. In addition, Presidio has begun work outside of the lucrative SCS market and is exploring other indications with undesired nerve activity. The company is actively engaged in targeted R&D projects for patients in other disease states who will potentially benefit from the company’s proprietary technology.
Job Summary:
The Director of Digital Solutions will architect, specify, and manage the development of mobile apps from custom implanted multigenerational Class III neuromodulation systems to iOS and Android mobile apps and will be securely connected to the cloud. The candidate will be responsible for all technical aspects of next gen cloud connected system and leverage external software developers to ensure high quality new product introduction per schedule. The candidate will need strong working experience of medical device cloud connected systems and working within requirements of medical and non-medical device software solutions.
The candidate shall develop a working knowledge of the system at both the high and low levels for the purposes of assuring the system has been thoroughly thought through, is documented, and tested such that it achieves the quality expected for a commercial Class III active implantable system. The candidate will also develop a deep understanding of the Quality Management Process such that they will be able to contribute to the design, development, and testing of the Product within those guidelines. The candidate will work with the Quality department to assure that all the process documentation is complete, reviewed, and approved, specifically Test Plans, Protocols, and Reports.
The candidate shall be able to work with both firmware and hardware engineers, the scientific staff, and field clinical staff to troubleshoot code for mobile application software and assist with development when required. At times this may require extended stays at locations within and outside of the US.
The candidate must have strong communication skills and established and proven success working with external development partners
Essential Duties and Responsibilities:
o Architect and work with vendors to specify and manage the development of mobile apps for iOS and Android
o Working with vendors to develop a secure cloud system to support data gathering and remote programming capabilities.
o Support software applications for Presidio Medical’s current and next generation SCS systems.
o Work hand in hand with firmware, hardware and systems engineering teams to manage requirements and scope, while delivering results on schedule.
o Hands-on lead and manage all phases of the application software development life cycle in a medical device environment, from initial concept through verification testing to market release, and post-market technical support.
o Document all phases of development within Presidio’s document control system
o Mentor, code, and provide guidance to junior engineering staff members
o Support modifications to existing designs for improved usability and reliability
o Develop efficient and high-yield manufacturing test software, and quickly resolve production software issues.
o Comply with all health and safety regulations, policies, and work practices.
o Comply with Presidio Medical's quality system requirements as well as any applicable regulatory requirements.
o Other duties as assigned.
Qualification Requirements:
Experience:
o Minimum of 15 years software development in safety oriented regulated industries, such as medical, automotive and defense
Knowledge/skills/Abilities:
o Managing and delivering complex mobile application software projects on time and with excellent quality
o Experience developing and deploying mobile application in the medical domain is a definite plus
o Ability to architect, design and analyze diverse solutions based on evolving requirements
o Extensive experience working through formal change control, knowledge medical device software guidance and regulations preferred
o Excellent knowledge on cloud connectivity and cybersecurity is a plus
o Demonstrated capability as a technical leader taking mobile application software from concept phase through development into volume production
o Strong foundation of software competency, with a passion for excellence
o Applicable programming skills with the ability to jump and make technical contributions.
o Previous startup experience, guiding software development through rapid growth cycles is a definite plus.
Education:
o Bachelor’s degree or higher in Electrical Engineering, Computer Engineering, Computer Science, Software Engineering, or related fields required.
Additional Position Details:
o Ideally the candidate would work out of South San Francisco, but a hybrid or remote approach is possible since many team members are geographically distributed.