Senior Project Manager-Medical Devices

GILERO•Durham, NC

8d•Hybrid

About The Position

Are you an experienced Project Manager with a passion for bringing innovative medical and drug delivery devices to life? At Gilero’s Durham's office, we’re looking for a Senior Project Manager to lead design and development projects in cutting-edge healthcare solutions. In this role, you’ll drive complex projects from concept to commercialization, ensuring they stay on track, on budget, and meet the highest quality standards. If you thrive in a fast-paced, collaborative environment where your expertise in project management, engineering, and client relations makes a real impact, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, and excellence — while offering outstanding career development and growth potential.

Requirements

BS in Engineering or 4-year technical degree.
PMP Certification (preferred).
Must be willing to work in the Durham office a minimum of 4 days a week.
8+ years of experience with 5+ years of experience as a Project Manager in Medical Devices.
Knowledge of medical device regulations (FDA/ISO).
Possess strong project management skills and can work alone or in teams.
Strong writing skills and/or data analysis.
Ability to communicate effectively with customers and vendors in a technical capacity.
Competent computer skills, including Excel and Word.

Nice To Haves

PMP Certification

Responsibilities

Organize project activities, lead the project team, prioritize and delegate tasks to team members in adherence with timelines and budget requirements.
Lead multi-year medical and drug delivery development projects consisting of electronic as well as disposable devices.
Ensure project scope is maintained and/or manage out-of-scope requests.
Forecast engineering resources for short/mid/long-term project needs.
Generate financial and project reports for internal and external communication.
Liaise with the client for routine project updates, build relationships with clients.
Support Business Development through project timeline and budget preparation for new opportunities as well as project extensions.
Facilitate internal and external project meetings.
Grasp technical details with an ability to assist the team in decision-making.
Manage ongoing project timelines and budgets.
Maintain documents relating to the overall project (project plan, user needs, etc.). Ensure deliverables are being met and the customer is satisfied.
Coordinate vendor activities (suppliers, third-party labs, manufacturers, etc).
Ensure team members comply with established QMS guidelines/procedures/work instructions.
Act as a project coach for more junior project managers. Advise on projects. Mentor junior team members and engineering interns.
Support company-wide project management objectives.
Support the recruiting process by participating in interviews for the project management team.