Paradromics is bringing to market the first high-bandwidth data interface between brains and computers. We envision a future where data is medicine and some of the hardest challenges in physical and mental health have been reframed as technical problems with clear solutions. By allowing direct readout and modulation of neural activity, brain computer interfaces (BCI) will act like a modem for the brain, allowing it to connect with restorative digital systems. Our first product will be an Assistive Communication Device for patients with severe combined speech and motor deficits as a result of paralysis.

We are seeking dynamic, curious, and driven individuals to join our Austin-based team. We offer a competitive compensation package with stock options, flexible PTO, and a friendly working environment.

Project Manager

Fulltime   ·   Austin, TX

Job Description

The Project Manager at Paradromics is responsible for advancing the organization’s core technologies into a final product design capable of manufacturing at scale and of withstanding the regulatory scrutiny for a Class III medical device. This includes monitoring and reporting on the entire development and manufacturing processes, ensuring internal stakeholders as well as external suppliers meet their commitments, and ensuring alignment across all parties. This position will work closely with engineering personnel and suppliers to provide overall project management, ensure both cross-functional communication and proper documentation of the project throughout all stages of development.

Requirements

• 4+ years’ experience as a Project Manager, preferably within a medical device company. Ideally experience in devices with active electronic devices (e.g. neuromodulation)
• Knowledge of process characterization studies and creation of qualification protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation)
• Ability to work effectively in a team environment with a diverse group of people
• Organization and ability to attain results on several projects simultaneously
• Ability to work independently under limited supervision to lead high visibility projects and execute in a timely manner
• Good oral and written communication skills
• Willingness to work in a fast-paced organization with shifting responsibilities.
• Leadership on project teams, providing project management responsibilities with the main focus on concept to launch.
• Working with suppliers, manufacturers, and/or internal manufacturing engineering resources
• Experience with ISO 13485 or FDA QSR
• Familiarity with common software programs (e.g., Word, Excel and PowerPoint) and GSuite platform
• Bachelor’s Degree in Engineering, Science or Technical field

Responsibilities

• Project planning and execution to ensure timely completion of tasks
• Planning, scheduling, and execution of activities within the framework of FDA Quality System Regulations and under FDA Design Controls.
• Project risks identification and mitigation
• Interface with all functional areas affected by the project including R&D, Engineering, Manufacturing, Quality, Regulatory, and suppliers
• Managing and reporting on project status and budgets; manages schedules and prepares status reports (written and verbal)
• Communication and engagement with stakeholders to ensure successful delivery of the project in alignment with all stakeholder needs and expectations
• Reviewing status of projects and budgets; manages schedules and prepares status reports
• Monitoring the project from initiation through completion
• Developing mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients

Qualified candidates should send cover letter and resume to HR@paradromics.com