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.
Job details are sourced from the employer's original posting.
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