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 Management
- Develop, 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 Documentation
- Lead 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 Activities
- Facilitate 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 BSC procedures, medical device regulations and standards.
- Regulatory and Compliance
- Ensure 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 Responsibilities
- Be 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 Knowledge
- Apply 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.