Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Essential Responsibilities:

Project ManagementDevelop, manage, and maintain project schedules, ensuring timely completion of deliverables.Track budgets and expenses, ensuring cost adherence and flagging deviations.Generate regular project status reports for stakeholders and leadership.Ensure proper resource allocation and manage project priorities.Change Management and DocumentationLead and generate change notifications, ensuring full compliance with documentation systems and processes.Present change proposals in regulatory forums and ensure approvals are obtained.Develop and route project-related documents through the change management system for formal approval.Participate in required trainings on change management and documentation systems.Coordination of ActivitiesFacilitate cross-functional team meetings to ensure alignment on project goals and timelines.Serve as the main point of contact for internal teams and external vendors, ensuring smooth execution of project activities.Coordinate with validation, automation, and quality teams to ensure project deliverables comply with procedures, medical device regulations and standards.Regulatory and ComplianceEnsure projects adhere to medical device industry standards and regulatory requirements.Attend regulatory meetings/forums to represent project changes and provide updates as needed.On-Site ResponsibilitiesBe physically present at the manufacturing site to monitor project progress and ensure alignment with production and automation needs.Provide hands-on support for troubleshooting and issue resolution related to project scope.Technical KnowledgeApply general knowledge with development lifecycles for industrial automation and software engineering.Collaborate with automation and controls teams to align on system integration strategies.

Required Qualifications:

Education: Bachelor’s degree in engineering, Industrial Automation, or related field.Experience: 3- 5 years of experience managing software and industrial automation projects, preferably in a medical device manufacturing environment.Knowledge of medical device regulatory requirements. Skills: Proficiency in project management tools (e.g., MS Project, Smartsheet).Familiarity with industrial automation systems (Rockwell, Siemens, Cognex, etc.).Experience with change management systems and document control processes.Strong organizational, communication, and leadership skills.Ability to manage multiple projects and priorities simultaneously.

Additional Requirements:

On-site presence is required.Ability to attend and complete internal trainings on change management and documentation systems.Experience working in regulated environments with focus on quality and compliance.

Work Environment:

The role is based on-site in a manufacturing plant environment and requires close coordination with engineering, automation, production, quality, and compliance teams. Occasional travel may be required for vendor coordination or regulatory meetings.