Project Manager, Engineering
Listed on 2026-06-20
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Engineering
Operations Manager
Job Summary:
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 advances PMO maturity through the development and deployment of standardized tools, templates, and reporting frameworks, ensuring alignment with regulatory requirements such as design controls, change management, and document control (e.g., DHF/DMR). Responsibilities include managing and communicating project definition, development milestones, project schedules, and project statuses for engineering and operational plant projects, and coordinating large‑scale manufacturing efforts domestically and internationally.
- Determine project responsibilities by identifying project phases, key stakeholders, and obtaining collaboration.
- Create and maintain comprehensive project documentation within design controls.
- Establish schedules, project plans, and specifications for all assigned projects.
- Measure and report on project status, financial performance, and go‑live dates.
- Set project specifications by studying requirements, completing technical studies, and preparing cost estimates.
- Coordinate and influence cross‑functional teams and external partners (e.g., vendors) to ensure timely execution of engineering and manufacturing projects.
- Enforce compliant project documentation practices, overseeing drawings, specifications, and engineering change records to adhere to quality system requirements (e.g., DHF/DMR, change control).
- Prepare status reports and summarize information for upper management.
- Education:
Bachelor’s degree. - Work Experience:
6+ years of progressive project management or PMO experience in a regulated industry, preferably medical device, life sciences, or pharmaceutical manufacturing. - Additional:
Proven ability to manage multiple projects and priorities with high autonomy and accountability. - Ensure projects are delivered on time, within scope, and within budget.
- Assist in defining project scope and objectives, ensuring technical and tangible feasibility.
- Support securing project approval.
- Measure project performance and report findings to senior management.
- Perform risk management to mitigate risks to the project and the organization.
- Travel:
Approximately 25% domestic and limited international travel. - Advanced skill level in Microsoft Project or similar program.
- Six Sigma Black Belt or higher certification.
- Advanced degree or PMP certification.
- Strong working knowledge of medical device quality systems and regulatory requirements (design controls, DHF/DMR, change management, CAPA, validation processes).
- Demonstrated experience leading complex, cross‑functional NPI projects.
- 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.
Salary Range: $ - $ per year. The actual salary will vary based on location, experience, and qualifications.
Medline Industries, LP is an equal opportunity employer. Experienced applicants are encouraged to submit their application.
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