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Teklysium Inc

Senior Program Manager – Medical Devices

Bothell, WA, US · On-site · Full-time

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About the role

Program ManagementStakeholder ManagementRisk Management
  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. All your information will be kept confidential according to EEO guidelines.