Agile Software Project Manager (FDA Experience)

We are looking for an Agile Software Project Manager with FDA experience for our Brain Computer Interface (BCI) system which allows our users to overcome motor difficulties in order to accomplish a variety of digital tasks.  The individual will be responsible for orchestrating the release of multiple regulated components of a larger regulated medical device system.   This position is located in Brooklyn, NY.  No agencies please.  

The individual in this role will be responsible for software project management within an IEC 62304 compliant agile software development procedure.   Our process is truly agile.  We are looking for an individual to work closely with engineering leads to support sprint planning, execution, demos and retrospectives.  

A greater responsibility will include management of individual phase reviews for each component and ensuring schedules and project-level challenges are addressed and mitigated.   Projects may include early feasibility, pivotal, pre-market submissions, post-market maintenance and research for software and firmware.

Our software team is a small group of talented and experienced individuals developing high quality and technically advanced software.   In this role, you will report to the Director of Software and be responsible for evaluating, assessing and managing schedules and helping to ensure the effectiveness of the software team.  

We are a lean, fast-paced, passionate team pushing the boundaries of what is possible in the neurotech space to dramatically improve the quality of life for millions of people globally: We want you to join us. 

Responsibilities  

• During early project phases help ensure consistent and predictable execution of our Agile software process
• Identify and work to mitigate project risks
• Strive to remove impediments to team success within the confines of a IEC 62304 procedure
• Own QMS phase reviews for software components
• Manage the convergence of multiple hardware and software components making up a complete release
• Coordinate schedules between HFE, Labeling, Regulatory and other teams to ensure design history file elements are completed on schedule
• Manage multiple software maintenance releases under various FDA pathways

Minimal Qualifications 

• Believer in Agile software development with experience using it successfully
• Previous project management experience on an approved FDA submission
• Experience in managing software releases within IEC 62304 procedures (will consider aviation or other industry with similar regulatory requirements for design controls)
• Bachelor’s degree
• At least 5 years experience in software leadership
• Experience with automated software testing
• Strong written communication and editing skills

Preferred Qualifications 

• Experience in development of implantable medical devices

Expected salary range: $145-$155k