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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.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II 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 Department Manager, this position will have direct responsibility for the manufacturing of components within a machining Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Williemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to setup basic legacy components and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Drive problem solving activities for basic machine or process issues.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program preferred.

Experience

• Minimum of 1-3 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Demonstrated understanding of the usage and care of mechanical equipment and inspection processes.
• Ability to use basic hand-held tools to perform preventive maintenance activities and install or change tools.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Strong verbal and written English language 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 tooling or tool holders. 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.

#SJ24

2nd shift: Monday- Thursday 3:30PM- 2:00AM
Weekend shift: Friday- Sunday 6:00AM-6:00PM

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II 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.

Shift: Fri-Sun; 6 am to 6 pm (paid lunch), 15% shift differential

Summary of Position

Reporting to Department Manager, this position will have direct responsibility for the manufacturing of components within a machining Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to setup basic legacy components and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Drive problem solving activities for basic machine or process issues.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program preferred.

Experience

• Minimum of 2-3 years’ experience in a regulated manufacturing environment.

Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Demonstrated understanding of the usage and care of mechanical equipment and inspection processes
• Ability to use basic hand-held tools to perform preventive maintenance activities and install or change tools.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Strong verbal and written English language 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 tooling or tool holders. 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.

Friday-Sunday: 6am to 6 pm with a paid lunch
36 (over time available)

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist II 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 Department Manager, this position will have direct responsibility for the manufacturing of components within a machining Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, perform basic setup and operate equipment, and perform visual and dimensional inspections on machined components.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Ability to operate and maintain production on equipment within the department. Ex. include Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes, Willemin Mill turns, various 3-4-5 axis mills, Anodize/Passivation Lines.
• Demonstrated ability to perform offsets and change tools to maintain efficient production with minimal support.
• Ability to setup basic legacy components and ensure the machine is ready for steady production.
• Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, etc.
• Regularly and as prescribed, perform preventive maintenance of equipment.
• Drive problem solving activities for basic machine or process issues.
• Completes and compiles necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to ensure inspection and traceability activities are properly documented and controlled, as needed.
• Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Other duties and responsibilities are assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Certification from a technical school program preferred.

Experience

• Minimum of 1-3 years’ experience in a regulated manufacturing environment.

Preferred Skills/Qualifications

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Demonstrated understanding of the usage and care of mechanical equipment and inspection processes.
• Ability to use basic hand-held tools to perform preventive maintenance activities and install or change tools.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Ability to effectively read and understand blueprints, specifications and procedures.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Strong verbal and written English language 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 tooling or tool holders. 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.

First Shift: Mon-Fri 6 am to 4:30 pm
50 hours