Medical Device Maintenance of Business Project Manager

Date: Jun 23, 2022

Location: US-MO-Saint Louis, Missouri, US

Company: Bausch & Lomb

Job Title: Medical Device Maintenance of Business Project Manager


Business Unit: US Operations


Organization/Department: US Engineering, Department TBD


Hiring Manager:  Dave Gruszczynski


Full Time / Contract:  Full Time


Position Summary: The Medical Device Maintenance of Business (MOB) Project Manager is responsible for managing MOB business critical projects aligned with the St. Louis Surgical Equipment Manufacturing site priorities.   The MOB projects ensure continuity of supply, provide enhanced product quality and support manufacturing cost improvements. This position will receive primary technical direction from the Surgical Equipment Portfolio Lead in Rochester, NY and from the R&D Engineering leadership at the St. Louis manufacturing facility in St. Louis MO.


Specific Job Duties:

1. Work with the site R&D and Operations leadership to identify and a prioritize Maintenance of Business projects in support of St. Louis surgical equipment manufacturing based on the following criteria:

  • Priority 1: Non-Conformance (NC), CAPA, Compliance, Product Recall, Customer Complaints, Critical Manufacturing Issues
  • Priority 2: Manufacturing Supply Chain Continuity (e.g. obsolete components)
  • Priority 3: Risk Mitigation (e.g. alternative sourcing of critical components)
  • Priority 4: Manufacturing Efficiency and Process Improvement, Cost Reduction (CIP).


2. Develop project resource plans, budgets, schedules and support annual operating plan budgetary activities and resource management associated with project execution.


3. Monitor and report on the overall projects cost performance against plan and manage MOB projects within budget.


4. Ensure project plans and timelines are in place for all planned activities including a detailed project charter/scope, risk assessment, and milestone schedule.


5. Manage process to accommodate new MOB requests and make appropriate trade-offs (e.g. schedule delays) with currently active projects as needed.


6. Chair regular management reviews and updates of progress against annual project goals and deliverables and communicate changes to project priorities and timelines.


7. Develop close working relationship with site leads and R&D resources to ensure alignment and balance of MOB project resource needs with other site and R&D projects.


8. Lead individual MOB projects within the project portfolio as appropriate.


9. Ensure project documentation is completed and approved per procedures.  Where necessary generated required report writing and documentation for DHF. 


10. Responsible for initiating and managing Quality Change Requests (QCRs) to completion.



Qualifications and Requirements:


Education:  Bachelor degree in Mechanical Engineering, Chemical Engineering, Material Science, Chemistry, Physics, or related discipline. PMP certification and Master’s Degree a plus, but not required. 


Work Experience:

  1. Knowledge and experience in medical device manufacturing processes.
  2. Ability to be successful within a matrix-reporting environment.
  3. Technical and managerial experience within an FDA regulated industry.
  4. Demonstrated experience with lean techniques and principles preferred.
  5. Demonstrated use of 6-Sigma skills and DOE skills highly desirable.
  6. An ability to analyze and manage technical issues across multiple technical disciplines.
  7. Strong leadership capabilities.
  8. Excellent project management, organizational, and documentation skills
  9. Proven track record of delivering to objectives.
  10. Significant change management experience.
  11. Technical transfer experience and an understanding of manufacturing.
  12. Strong teamwork and negotiation skills and the ability to influence without authority.
  13. Demonstrated ability to work across organizational boundaries.
  14. Excellent communication skills and ability to influence at all levels of the organization.
  15. Excellent verbal, writing and computing skills.  Familiar with MS Office, MS Project, CAD and statistical evaluation software.


Managerial Reporting and Responsibilities: There are no direct reports for this position.


Work Location:  Surgical Equipment Manufacturing plant, St, Louis, MO.