Senior Program Manager – Medical Devices

  • Full-time

Company Description

 

    Job Description

    Role & Responsibilities:

    • Serve as the onsite point of contact for program management, functional leads, SMEs, and stakeholders.

    • Develop and manage project plans, milestones, resources, deliverables, and schedules.

    • Track project progress, risks, dependencies, action items, and deliverables using Smartsheet.

    • Lead daily coordination meetings, weekly status reviews, and monthly governance meetings.

    • Manage scope, priorities, change control, and milestone acceptance.

    • Coordinate onsite and offshore teams, resource planning, and knowledge transfer.

    • Monitor project KPIs, delivery timelines, quality, and documentation.

    • Ensure timely escalation and resolution of project risks and issues.

    Requirements:

    • Bachelor's degree in Engineering, Life Sciences, or a related field.

    • 12+ years of project/program management experience.

    • Experience in medical devices or other regulated industries.

    • Proven experience managing onsite and offshore delivery teams.

    • Experience with fixed-price and milestone-based projects.

    • Knowledge of medical device design controls, DHF, FMEA, risk management, and V&V documentation.

    • Familiarity with ISO 13485, ISO 14971, FDA quality requirements, and EU MDR.

    • Strong leadership, stakeholder management, communication, and problem-solving skills.

    Additional Information

    All your information will be kept confidential according to EEO guidelines.

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