Summary:

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.

Essential Responsibilities:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.
  • Ability to attend and complete internal trainings on change management and documentation systems.
  • Experience working in regulated environments with focus on quality and compliance.
• 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.

Work Methodology:

• 100% Onsite
• Full Time Opportunity
• ​​​​​Administrative Shift (weekends and overtime may also be required, if necessary)
• 11 months of 1st contract.
• Professional Services