Description

Status Full-time 30 Hours, Salary, Exempt 

Department Operations

Location Richland, WA

Reports To Sr. Project Manager

Travel 10 - 25%

GammaTile®

The journey for a patient with a brain tumor is an emotional one. Newly diagnosed patients usually present in the emergency department following a change in vision, balance, or cognitive function. Their world is soon turned upside down in a race to surgery. Far too many patients (~50% for glioblastomas) recur within a few months and are forced, with dedicated family members and clinicians, to navigate treatment options yet again. Unfortunately, it has been over a decade since an innovative option has been cleared by FDA…until GammaTile® Therapy! GT Medical™ technologies exists for those patients, care givers, and clinicians who need a better option. Our Corporate Purpose is to Improve the Lives of Patients with Brain Tumors and that drives us every day. 

GammaTile® Therapy is supported by 100 amazing teammates who collaborate organically, challenge appropriately, and are consumed with assisting the next patient on the table. We have a great core team, an innovative solution, and the finances to support more growth. We are now in need of a Project Manager for our manufacturing facility in Richland, WA. If you have a heart for patients with brain tumors, excellent project management skills, and and a good balance of strategy and tactical execution, we’d love to talk to you!

Position Summary

This role is responsible for managing all aspects of complex projects supporting integration activities as it relates to manufacturing processes, systems, and people. This individual will drive the accomplishment of project objectives through detailed planning, leveraging best practices, risk identification and mitigation, resource alignment, evaluation of priorities, precise communication, and establishment of robust governance and progress reporting. 

Job Duties/Responsibilities

• Develop, drive, track and report on integrated program plans, detailed project schedules, critical path analysis, project and product risks, and program deliverables.
• Coordinate activities and resources across multiple departments and facilities, including Operations, Customer Operations, Manufacturing, Marketing, R&D, Quality, Clinical, and Regulatory Affairs.
• Support project budget development and ensure annual project budget targets are met by overseeing project costs including capital expenditure and expenses and related reporting.
• Support PMO department development and deployment of robust governance and processes to initiate, execute and track progress of GT Medical Technology projects. 
• Demonstrate ability, confidence, and strong communication skills to lead project, portfolio, and status meetings with internal cross-functional teams, external partners, and senior executives.
• Provide guidance on priorities, scheduling, and resolution of open issues, while maintaining compliance in a regulated product development environment.
• Consult and provide advice, facilitate discussions, and resolve conflict; establish trust; build and use cross-functional relationships to accomplish work objectives.
• Monitors and communicates the progress of the delivery and ensures timely and effective communication of the status in terms of cost, forecast, schedule and assessment of risks/issues
• Adheres to the Company’s purpose operating principles, building a positive and productive team culture.
• Comply with Company policies and procedures.
• Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
• Other duties as assigned. 

Requirements

Qualifications

• BS Degree in Project Management or relevant degree. 
• Minimum 3 years of years of experience as a program/project manager.
• Minimum 3 years of relevant work experience in medical device or pharmaceutical industry.
• Project Management Professional (PMP) preferred. 
• Ability to establish business cases within a project in consultation with business partners.
• Familiarity with key FDA medical device regulations (IEC 62304, ISO 14971, ISO 13485).
• In-depth knowledge of the product development process and medical device design control requirements, including a working knowledge of GMP’s and ISO standards.
• Ability to lead, collaborate, challenge and influence peers, subordinates, and senior management.
• Ability to prepare for and lead technical reviews and decision meetings. Can clearly document options and trade-offs to facilitate problem solving.
• Self-accountable for flawless project execution.
• Demonstrate clear bias for action and a sense of urgency.
• Demonstrated ability to successfully influence people and teams at levels without direct authority.
• Demonstrated analytical, decision making, prioritization and problem-solving skills.
• Ability to manage multiple priorities.
• Follow all safety rules and safety procedures.
• Ability to understand federal and state regulations and company policies and procedures related to radiation safety.
• Excellent written and verbal communication skills.
• Proficient in using Microsoft office programs (Word, Excel and PowerPoint)
• Proficient in using MS Project and Visio.
• Willingness to work a flexible schedule. 
• Able to travel for work as needed.
• Satisfactorily pass comprehensive background screening. 

Physical Demands/Working Conditions

• Typical work environment for a professional office and home office space and occasionally works in a laboratory, supply room, and/or clean room environment.
• Occasional exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals.
• Largely a stationary role with some moving from place to place.
• Constant use of a computer, keyboard, mouse, monitor and other office equipment.
• Occasional use of laboratory equipment.
• Requires some finite hand/eye coordination.
• Occasionally picks up, carries, and moves items up to 30 lbs.
• Some evening and weekend work depending upon workload.
• Some overnight travel will be required for work, events, and training