Note: The job is a remote job and is open to candidates in USA. Medline Industries, LP is seeking a Project Manager to partner closely with engineering, quality, operations, and senior leadership to manage complex medical device new product introductions. The role involves advancing PMO maturity, managing project schedules, and ensuring compliance with regulatory requirements.
Responsibilities
- Determines project responsibilities by identifying project phases and is responsible for identifying key stakeholders and obtaining their collaboration. Creates and maintains comprehensive project documentation inside design controls
- Establishes schedules and project plans and specifications for all assigned projects. Measure and report on status of the project both financially and go-live dates
- Set Project specifications by studying project requirements, and standards; completing technical studies and developing preparing cost estimates
- Coordinate and influence cross-functional teams and external partners (e.g., vendors), ensuring accountability, alignment, and timely execution of engineering and manufacturing projects
- Establish and enforce compliant project documentation practices, including oversight of drawings, specifications, and engineering change records, ensuring adherence to quality system requirements (e.g., DHF/DMR, change control)
- Prepare status reports by summarizing information and reporting to upper management
Skills
- Bachelor's degree
- 6+ years of progressive experience in project management or PMO roles within a regulated industry, preferably medical device, life sciences, or pharmaceutical manufacturing
- Proven ability to manage multiple projects and priorities with a high degree of autonomy and accountability
- Ensure that all projects are delivered on-time, within scope and within budget
- Assist in the project scope and objectives, involving all related parties ensuring technical and tangible feasibility
- Support securing project approval
- Measure project performance and report accordingly to senior management
- Perform risk management to mitigate risks, for both the project and any potential risk to business operations
- This position will require approximately up to 25% domestic and limited international travel
- Advanced skill level in Microsoft Project or similar program
- Six Sigma Black Belt or higher certification a plus
- Advanced degree or PMP certification preferred
- Strong working knowledge of medical device quality systems and regulatory requirements (e.g., design controls, DHF/DMR, change management, CAPA, validation processes)
- Demonstrated experience leading complex, cross-functional projects focused on NPI
- Strong analytical, problem-solving, and risk management skills with the ability to translate data into actionable insights
- Excellent communication and stakeholder management skills, including experience presenting to senior leadership
- Experience mentoring or leading less experienced team members and driving process improvements within a PMO structure
Benefits
- Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
- This role is bonus and/or incentive eligible.
- Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
- For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
Company Overview
Company H1B Sponsorship