TOMZ Corporation is looking for a motivated Associate Project Manager to join our organization. A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. TOMZ maintains a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.
Summary of Position
Reporting to the Chief Commercial Officer, this position is responsible for assisting the planning, execution, monitoring, and completion of projects with cross-functional teams to successfully managing the development of new and existing Projects. With assistance utilizing project management and system tools to track projects deliverables.
Essential Functions
- Assist all functional stakeholders to manage and coordinate activities related to the development, documentation and validation of medical devices utilizing TOMZ project tracker.
- With Guidance from Team Leader, support members of the organization understand their roles and responsibilities. Motivate and inspire each other to achieve project goals and objectives.
- Support the implementation of Change Management process to effectively manage changes to project scope, schedule, and objectives defined by the customer while minimizing disruptions. This requires assessing impacts, obtaining approvals, and communicating changes to relevant stakeholders.
- With guidance, generate and maintain project plans, schedules, task lists and project risk registers that enable the team to execute project activities.
- Coordinate activities across different functional groups within the company, customers, and suppliers to ensure successful completion of project goals and milestones.
- Track project health in terms of schedule, budget, and technical risks.
- Prepare and present project status reports to internal and external stakeholders as needed.
- Proactively anticipate project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
- Create and maintain documentation per company procedures and 13485 requirements.
- With support lead internal and customer meetings and visits, and day-to-day customer communication and documenting with weekly meeting minutes. Providing
- Support interface with suppliers to drive schedules and manage priorities.
- Support financial aspects of internal and customer programs.
- Travel is required 5-10 % of the time to visit customers and other sites.
- Other duties as assigned.
Qualifications:
Education/Experience
- 4-Year degree or 2+ years manufacturing/equivalent of directly transferrable industry work experience and prior experience with project management
- Experience in a regulated engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred (preferably in a Medical Device)
Qualifications
- Must be able to support technical drawings, specifications, process manufacturing knowledge.
- Ability to communicate complex ideas, Project status and risks to internal and external stake holders.
- Willingness to travel
- Must maintain high ethical standards.
Preferred Skills
- Must demonstrate good organizational skills.
- Strong computer skills, including the MS Office suite and MS Project.
- Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information.
- Technical report preparation and formal presentation skills.
- Excellent verbal and written communication skills
Physical Demands
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is frequently required to stand, and/or walk. The employee must occasionally lift and/or move up to 30 pounds while moving components, fixtures, equipment and/or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.