Senior Project Manager - Medical Devices

Gilero; Durham (NC); On-site; USD 130,000 - 170,000; Full time

Job summary

Gilero Senior Project Manager - Medical Devices in Durham, NC is responsible for leading complex multi-year development projects from concept to commercialization, ensuring timelines, budgets, and quality standards are met. The role interfaces with clients, vendors, and internal teams to drive successful outcomes.

The candidate will oversee project planning, resource forecasting, budgeting, and reporting, while mentoring junior staff and supporting business development activities.

Qualifications

• BS in Engineering or 4-year technical degree.
• PMP Certification preferred.
• Willing to work in the Durham office a minimum of 4 days a week.
• 8+ years of experience with 5+ years as a Project Manager in Medical Devices.
• Knowledge of medical device regulations (FDA/ISO).
• Strong writing skills and/or data analysis.
• Ability to communicate effectively with customers and vendors in a technical capacity.
• Proficient in Excel and Word.

Responsibilities

• Organize project activities, lead the project team, prioritize and delegate tasks to team members within timelines and budget requirements.
• Lead multi-year medical and drug delivery development projects consisting of electronic as well as disposable devices.
• 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 and build relationships with clients.
• Support Business Development through project timeline and budget preparation for new opportunities and extensions.

Skills

Project management

Leadership

Communication

Budgeting

Regulatory knowledge (FDA/ISO)

Data analysis

Advanced Excel

Education

BS in Engineering

Tools

Microsoft Office (Excel/Word)

Job description

Senior Project Manager - Medical Devices

FullTime Durham, NC, US

9 days ago Requisition ID: 1024

Salary Range: $130,000.00 To $170,000.00 Annually

Are you an experienced Project Manager with a passion for bringing innovative medical and drug delivery devices to life? We are looking for Senior Project Managers 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. Positions open in our offices located in Chicago, IL, Carlsbad, CA, and Durham, NC.

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.

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.

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.

Personal Attributes

• Meets Gilero Core Values: Collaboration, Integrity, Innovation, Excellence.
• Comfortable and productive in a fast-paced, entrepreneurial environment.
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities, and providing high-quality service to internal and external clients.
• Commitment to excellence and quality service to external and internal customers.
• Commitment to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero, we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company-provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.