HireFocus LLC · 18 hours ago
Senior Program Manager
Houston, TX
Full-time
Onsite
Senior Level
5+ years expHireFocus LLC is seeking a Senior Program Manager to lead the Project Management team in overseeing project schedules, reporting, and resource planning throughout the project lifecycle. The role requires hands-on leadership to drive projects and initiatives of medium to high complexity while ensuring compliance with medical device regulations.
Staffing & Recruiting
Hiring Manager
Joe Pitino
Responsibilities
Drive the development and management of project team to deliver a project plan covering all company functions to ensure timely delivery of all elements of the EQR endoluminal robotic system for IDE and de Novo submissions
Coordinate across company R&D functions to ensure the compliant development of medical devices, instruments, and accessories to FDA CFR Title 21 Part 820 and ISO 13485:2016 design control regulations and Design Control procedures and work instructions
Oversee the creation of Design Control documentation and Design History Files
Adhere to applicable ISO and regulatory standards during product development
Provide technical leadership around the FDA CFR Title 21 Part 820 and ISO 13485:2016 requirements on Design Control to the project team
Possess a deep understanding of our medical devices and their specific needs
Drive and track project performance, specifically to analyze the successful completion of short and long-term goals
Manage resource availability and allocation for each assigned project
Identify potential risks or issues that may impact project timelines, budgets, or product quality. Work with the leadership to develop mitigation plans and escalate critical issues appropriately
Foster effective communication and collaboration among team members and departments involved in projects
Facilitate regular meetings, ensure action items are addressed, and track progress
Qualification
Required
Strong program management skills, with significant demonstrable experience in medical device design control and 510(k) or de Novo
Innovative, detail orientated, goal orientated, and self-motivated
Team-centric work ethic
Possess constructive problem-solving attitude while dealing with time demands, incomplete information or unexpected events
Strong ability to positively influence the actions of others and leverage the skills of project partners
Drive and embrace the value of corporate culture
Proficient in project management software (e.g., MS Project)
Deep knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices
Maintains a high degree of integrity and professionalism
Strong verbal and written communication skills at all levels of the organization
Strong ability to communicate effectively with all levels within the organization and interface with customers
Bachelor's degree or advanced degree in Engineering or Science related field
Minimum of 5 years' experience working with FDA CFR Title 21 Part 820 and ISO 13485
Active Project Management Professional Certification (PMP)
Preferred
Project management in medical device product development
Deep understanding of medical device quality system constructs
Familiarity with compliance standards such as 60601 and 80601
Robotics experience preferred
Software design experience preferred
Company
HireFocus LLC
HireFocus is a recruiting firm formed from a reaction to the current state of the recruiting industry.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase