Job Application: Project Manager

Title: Project Manager

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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a motivated Project Manager to join our organization. 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 Director of Engineering, this position is primarily responsible for coordinating and managing the development, documentation and validation of new customer products, and the modification of existing production products.

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. 
  • Prepare and present project status reports to internal and external stakeholders.
  • Proactively anticipate project risks and issues, and carefully formulate and implement risk mitigations and corrective/preventive actions.
  • Create and maintain documentation per company procedures and 13485 requirements.
  • Coordinate and direct customer meetings and visits, and day-to-day customer communication.
  • Interface with suppliers to drive schedules and manage 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.  Make department managers aware of project team strengths and weaknesses with the goal of building company-wide project management skills.
  • Other duties as assigned

QUALIFICATIONS:

  • A Bachelors’ degree in an engineering discipline with a minimum 5 years of industry experience.
  • Certified Project Management Professional required.
  • Experience in a regulated engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred (preferably in a Medical Device Manufacturer).
  • 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 the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • 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.
  • 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 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.

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