Position Summary
This role serves as a project manager within the Instrument Operations team, providing strategic oversight of high-impact initiatives that drive product/process development, product/process enhancements, and lifecycle management. These efforts are aimed at strengthening our Instruments Manufacturing capabilities and efficiencies to support market position and addressing the evolving needs of our customers. In addition, this role contributes to continuous improvement of the Instruments Operations Project Management framework.
Working Conditions (Summary)
The position may require remaining in a stationary position for prolonged periods, ascending and descending stairs, ladders, and ramps, wearing PPE, operating heavy machinery, and moving objects up to 50 pounds. Domestic travel is 5% and international travel is 5%, for a total travel requirement of 10%.
Primary Duties
- Leads project teams, ensuring projects' scope, schedule, budget, and quality requirements are met
- Aligns projects' goal and priority with organizational strategy
- Shapes business cases, charters, and benefit/value tracking
- Leads the development of project plans, schedule and budget estimation, and resource allocation
- Conducts or assists with feasibility studies, vendor evaluations, and proposal reviews, ensuring compliance with project standards
- Troubleshoot and utilize problem-solving tools to resolve issues with process and/or product.
- Perform reviews related to risk analysis, change control, verification, validation, and other functions within the department.
- Define, review, and check product Bill of Materials (BOM), assembly instructions, and test procedures for implementation into Manufacturing.
- Maintains regular communication with stakeholders, clarifying expectations, and providing status updates on project milestones, risks, and issues/solutions
- Promotes adherence to project management best practices, support team development, and ensure quality control throughout project execution
- Leads cross-functional, cross-site, multi-country team coordination
- Proactive project risks management in identifying critical risks and implementing robust mitigation plans
- Perform all work in compliance with company quality procedures and standards
- Support change control processes or lead activities as needed
- Perform other duties as assigned
Qualifications
- Bachelor degree required in Engineering, Technology, Life Science, Business, Project Management
- Education Substitution: In lieu of a Bachelor's degree, 4 years of additional relevant experience, defined below, will be accepted.
- 5+ years of professional related experience with degree (Program/project management within a PMO or similar environment)
- or 9+ years of professional related experience in lieu of degree (Program/project management within a PMO or similar environment)
- Regulated manufacturing environment experience, ideally within IVD, medical device, or life sciences, including knowledge of ISO 13485 and FDA 21 CFR Part 820.
- Proven track record managing product lifecycle or manufacturing process and systems projects from concept through launch with accountability for scope, schedule, budget, and compliance.
- PMP Certification preferred
Knowledge, Skills, and Abilities (KSAs)
- Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
- Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
- Effective Presentation Skills – including the ability to present technical data
- Demonstrates assertiveness and confidence in the face of a challenge
- Collect and analyze data to drive informed decision-making to improve performance and identify issues
- Planning objectives and strategies to achieve them within a set timeline
- Skilled in project and resource management tools (e.g. MS Project, Planner, Smartsheet, Planisware, or equivalent
- Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance
- Project Planning & Execution, Project Leadership, Project Budget Management, Project Risk Management, Stakeholder Management
Learn more about this Employer on their Career Site
