Senior Medical Device Project Manager: Lead Complex Programs

NCBioImpact; Durham, Northern (NC, KY); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Annual bonus plan

Medical coverage (BCBS)

Dental and vision

Company-provided life insurance

Short-term and long-term disability

401(k) with match

LinkedIn Learning access

Job summary

Gilero in Durham, NC is seeking a Senior Project Manager to lead multi-year medical device development projects, including electronic and disposable devices. You will manage scope, budget, and timelines, while liaising with clients and guiding junior staff.

Applicants should have 8+ years in project management for medical devices, FDA/ISO knowledge, and strong communication skills. This role requires on-site presence in Durham with collaboration across teams.

Qualifications

• 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).
• 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.

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.

Skills

Project management

Writing skills

Data analysis

Communication

Coaching/mentoring

Education

BS in Engineering or 4-year technical degree

Tools

Excel

Word

Job description

Gilero in Durham, NC is seeking a Senior Project Manager to lead multi-year medical device development projects, including electronic and disposable devices. You will manage scope, budget, and timelines, while liaising with clients and guiding junior staff.

Applicants should have 8+ years in project management for medical devices, FDA/ISO knowledge, and strong communication skills. This role requires on-site presence in Durham with collaboration across teams.