Project Manager, Engineering
About The Position
The PMO Engineer partners closely with engineering, quality, operations, and senior leadership to manage complex, cross-functional, medical device new product introductions (NPI). The role is responsible for advancing PMO maturity through the development and deployment of standardized tools, templates, and reporting frameworks, while ensuring alignment with regulatory requirements such as design controls, change management, and document control (e.g., DHF/DMR). Responsible for managing and communicating project definition, development milestones, project schedules, and project statuses in the development of Engineering and Operational plant projects. Coordinate and manage large scale manufacturing and for Medline Industries both domestic and international.
Requirements
- 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.
- Advanced skill level in Microsoft Project or similar program.
Nice To Haves
- 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.
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.
Benefits
- health insurance
- life and disability
- 401(k) contributions
- paid time off
- Employee Assistance Program
- Employee Resource Groups
- Employee Service Corp
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What This Job Offers
Job Type
Full-time
Career Level
Senior
