TOMZ Corporation is looking for a 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. Those include 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 primarily responsible for coordinating with cross-functional teams to successfully managing the development of new and existing Projects. Utilizing project management and system tools to track projects deliverables.
Essential Functions
- Manage and coordinate activities related to the development, documentation, and validation of medical devices.
- 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 utilizing project tracker.
- Prepares and presents project status reports to internal and external stakeholders.
- 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.
- Coordinates and directs customer meetings and visits, and day-to-day customer communication.
- Interfaces with suppliers to manage schedules and priorities.
- Manage financial aspects of internal and customer programs.
- Perform post-project reviews to analyze reasons for project issues that can be addressed and prevented in future projects.
- Support team members to strengthen and achieve company-wide initiatives.
- Other duties as assigned.
Qualifications:
- 4-Year degree or 5+ years manufacturing/equivalent of directly transferrable industry work experience
- Experience in manufacturing in a regulated engineering/manufacturing environment.
- Must be able to fully interpret technical drawings, specifications, process capability, and CNC manufacturing knowledge.
Preferred Skills:
- Ability to communicate complex ideas, Project status and risks to internal and external stake holders.
- Willingness to travel, if required.
- Must maintain high ethical standards.
- Must demonstrate good organizational skills.
- Strong computer skills, including Excel, 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
- Demonstrated ability to work in a fast-paced environment.
- Self-motivated with a can-do attitude.
- Customer-centric mindset.
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 occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files 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.