• Project planning, risk management, project execution and communication to all levels of the organization.
• Management of multiple small projects or one large project; drives for accountability within self and others.
• Responsible for oversight of facility start-up (including design, specifications, and construction)—driving project deliverables, including schedule and budget.
• Oversee of all phases of a Product Transfer, from Detailed Planning, Execution, Validation and through Regulatory Submittals.
• Manage numerous projects and project teams across the organization, including but not limited to, Product/Production Transfer from Inari Headquarters, Installation, Qualification, and Scale of Production Lines.
• Analyze current operational processes and performance, recommending solutions for improvements
• Works with management team at local and corporate to ensure smooth  involvement with the projects deliverables and quality standards.
• Communicate with a variety of stakeholders at all levels effectively, including executives with differing priorities.
• Develop routine dashboards, reports and KPI´s that effectively communicate progress, risk, timelines and achievements of the project plans.
• Develop and deliver formal communications, including presentation skills when needed.
• Take ownership of hands-on management and tracking of overall team progress and provide detailed management status reports and updates.
• Coordinates Internal and external resources to execute and meet deadlines
• Ensure that project remains within budget
• Any additional duties as assigned

Qualifications:

• Bachelor’s in engineering and preferably with Project Management education.
• PMP certification desirable
• Minimum 5 years of experience managing large projects with preferable experience managing projects /
• 5+ years experience in transfers in the Medical Device Industry.
• Extensive experience in facility construction project management and/or production transfer, qualification, and scale.
• Experience in FDA/ISO/QSR standards and requirements.
• Experience in Quality System Regulations (QSR) 21 CFR 820, ISO 13485, and MDR.
• Experience in start-up company desirable
• Availability to travel  
• Lean/Kaizen/Continuous Improvement Capabilities.
• Experience with developing, implementing, and monitoring process improvement initiatives, project management frameworks and methodologies.
• Demonstrated track record in project management, production transfer, production scale and in establishing priorities and meeting deadlines.
• Strong leadership and interpersonal skills, ability to work with others and accomplish objectives.
• Capable of performing under the pressure of multiple competing deadlines while maintaining a cooperative and constructive working relationship with others.
• Outstanding verbal & written communication skills both English and Spanish.
• High level of enthusiasm, motivation, and results oriented
• Detail oriented