Senior Program Manager – Medical Devices

Job Description Role & Responsibilities:

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

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

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

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

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

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

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

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Ensure timely escalation and resolution of project risks and issues.

Requirements:

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

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12+ years of project/program management experience.

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Experience in medical devices or other regulated industries.

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Proven experience managing onsite and offshore delivery teams.

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Experience with fixed-price and milestone-based projects.

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

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

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