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TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a motivated Application Engineering 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 certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with Quality Engineering, Control and Assurance continuation development support for continuous improvement of manufacturing processes.

Essential Functions

• Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans.
• Leads on strategic initiatives to improve Quality Processes and Systems.
• Owns the development and/or update of Risk Management files in cooperation with cross-functional engineering teams, operations and customers.
• Supports the procurement and qualification of capital equipment.
• Operates and programs advanced measurement equipment including Vision Systems and CMMs.
• Authors Inspection Plans and defines process controls. Defines Test Method.
• Subject Matter expertise of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
• Execution and evaluation of Test Method Validations.
• Creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Initiate and/or consult in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
• Performs process qualifications, analyzes data and initiates corrections or corrective actions as required
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, resolving quality issues through the CAPA process.
• Defines and Measures KPI’s for New Product Introduction.
• Interfaces with the customer and meets all defined deliverables.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
• Generate ECOs for the release of Quality Engineering documentation.

Qualifications:

Education/Experience

• Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.
• Minimum of 0-4 years’ experience in a regulated manufacturing environment.
• Engineering degree and 7+ years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming. (12+ years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree)

Qualifications

• Ability to travel up to 20%.
• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (Visio, Project, Outlook, Word, Excel, and PowerPoint)
• Strong verbal and technical writing capabilities (English language).
• Expertise is statistical techniques, GD&T, process validation, and Metrology.
• Demonstrated ability to work in and lead teams through large scale projects.

Preferred Skills

• ASQ CQE or CRE.
• Expertise in 3D modeling Solid Works, Unigraphics, Mastercam, Solid Edge, etc.
• Six Sigma Green or Black belt.
• Certifications in DMIS programming preferred
• Regulated manufacturing industry experience preferably Class I, II and/or III Medical Device manufacturing experience. (exp: Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).

Join our TOMZ family in CT!! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Facilities Technician 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 the Facilities Manager, The Facilities Technician II will have direct responsibility for preventive maintenance, repairs and improvements of all support equipment around the facility. 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 highest level of cleanliness and safety possible in support of our mission to foster a desirable work environment for all employees and guests to our facility.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Perform and document routine preventive maintenance activities in various areas of the facility. Ex. Compressor room, HVAC systems, Mist Collector units, etc.
• Lead projects throughout the facility focused on cosmetic enhancement, functional improvement, or to support safety initiatives.
• Direct and support full machine cleanouts to remove chips and change coolant and basic perform machine repair.
• Operation of the Chip Spinner to reclaim coolant and separate from metal chips.
• Must 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).

Experience

• Minimum of 3-5 years’ experience in facilities maintenance.

Preferred Skills/Qualifications

• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Ability to use basic hand-held tools to support maintenance activities.
• Forklift and OSHA training required.

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 50 pounds while moving equipment, parts, coolant, metal chip pans, etc. 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 motivated Maintenance Technician 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 certified to ISO 13485.

Summary of Position

Reporting to the Facilities Manager, this position will have direct responsibility for preventive maintenance, repairs and improvements of all support equipment around the facility. 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 highest level of cleanliness and safety possible in support of our mission to foster a desirable work environment for all employees and guests to our facility. Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.

Essential Functions

• In the absence of a supervisor, help coordinate daily production schedules within area and drive solutions for other issues that directly impact production
• Perform and document routine preventive maintenance activities in various areas of the facility. Ex. Compressor room, HVAC systems, forklift, hoists, etc.
• Lead projects throughout the facility focused on cosmetic enhancement, functional improvement, or to support safety initiatives.
• Direct and support full machine cleanouts to remove chips and change coolant and basic machine repair.
• Operation of the Chip Spinner to reclaim coolant and separate from metal chips.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Weekly/monthly inspections
• Timely completion of facilities requests.
• Additional duties/responsibilities will be required, but not noted, per the Plant’s needs.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Minimum of 3-5 years’ experience in facilities maintenance.

Preferred Skills/Qualifications

• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Ability to use basic hand-held tools to support maintenance activities.
• Demonstrated coaching or training skills to drive departmental and company objectives.
• Forklift and OSHA training required.
• Ensure completion of managerial duties in the absence of manager.
• Help to schedule/work with outside contractors
• Ensure completion of facilities requests
• Help to delegate tasks given by manager and follow up for completion.

Physical Demands

• Occasionally lift and/or move up to 50 pounds.
• Frequently sit and/or stand.
• Use of hands to fingers well being able to handle and/or touch objects tools or controls.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Operations/Material Support 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.

Summary of Position

Reporting to the Supply Chain Manager, this position is responsible to support operation with product flow as needed as well as managing all raw materials required to support operations and manufacturing at TOMZ corporation. A company specializing in high-precision metal machining, finishing, assembly, and anodizing for Medical Devices. The successful candidate will maintain the highest level of traceability in handling the receipt, storage, and distribution of raw materials, ensuring smooth support for manufacturing processes while adhering to regulatory and quality standards.

Essential Functions

• Receipt and incoming inspection of all raw materials.
• Appropriate storage of all raw materials including ERP transactions and physical locations.
• Issue raw materials to manufacturing operations.
• Perform and document routine cycle counts to ensure proper inventory levels are maintained.
• Print Job Travelers as required to support production flow.
• Perform the “SAW” operation for all required materials prior to issuing to production floor.
• Ensure proper material control, identification and traceability is maintained for conforming and nonconforming material through the manufacturing processes.
• Monitor and order office and shop supplies.
• Order production tooling and enter into inventory when received.
• Put away tooling.
• Support manufacturing as needed.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 2-5 years’ experience in a regulated manufacturing environment.

Qualifications

• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Demonstrated ability to manage inventory levels.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• Ability to use basic hand-held tools and inspection equipment to support receiving inspection activities.
• Forklift training required.

Physical Requirements

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
• Perform keyboard entries with possible frequent operation of a computer.
• Ability to use power tools as needed.
• As needed to comply with safety requirements - need to wear safety equipment such as cut resistant gloves, safety glasses, hearing protection, steel toe and slip resistant shoes.

TOMZ Corporation is an Equal Opportunity Employer.

Join our team!! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Senior Machine Maintenance Technician 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

The purpose of the Senior Machine Maintenance Technician is to provide production equipment support for all equipment allocated to the Factory as well as to assist engineering with production-related projects. Routinely works with Plant Maintenance to coordinate jobs and projects. The Senior Machine Specialist will take the lead in the implementation and the decision-making process on best practices for the maintenance group. The position is also responsible for creating solutions and providing technical support to enhance production reliability through concerted efforts with cross functional teams.

Essential Functions

Duties and responsibilities include, but are not limited to:

• Adherence to all department safety measures and work instructions.
• Accountable for personal safety, the safety of co-workers and promoting a safe work environment.
• Repair and maintain all production equipment, both electrical and mechanical.
• Assist engineering as required with special machine related projects.
• Work with CONC and PLC controlled machines.
• Routinely work in electrical control panels of production equipment to troubleshoot electrical problems.
• Arc Flash certified worker to work “live” electrical control panels.
• Working understanding of precision measuring instruments used in troubleshooting.
• Read and interpret diagrams, schematics and specifications related to equipment operation.
• Monitor, modify, or write programmable ladder logic circuits as needed for existing or new installations.
• Create electrical drawings, PLC programs to be used for troubleshooting of modified equipment.
• Install electrical, air and data drops to equipment and machines.
• Work with outside contractors for equipment repair of production machines as needed and verify completion accuracy.
• Design and implement electrical circuits and technologies for support of production equipment.
• Initiate or enhance the preventative maintenance schedules for production equipment.
• Calibrate equipment using general and special purpose test equipment.
• Facilitate equipment modifications, upgrades, overhauls, and root cause failure analyses.
• Ensure respective area is complaint with 5S Standards.
• Maintain daily log of work in established systems.
• Support ISO 13485 initiatives.
• Assist in training individuals with less experience and tenure on established maintenance standards and practices.
• Project initiation and improvement ideas to better production and the business.
• Purchase repair parts, tools, and supplies in appropriate ERP software.
• Provide input for annual department budget planning.
• Ability to work flexible hours (including overtime) to accommodate production working hours as needed.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Associate degree in a technical related field or equivalent experience

Experience

• Minimum 10 years’ experience in the Equipment Maintenance Field

Qualifications

• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Maintains accuracy, is detail oriented, and completes tasks in a timely manner.
• Prior experience with CNC and PLC controlled equipment.
• Experience with MS Office Programs.
• Ability to perform routine maintenance of CNC manufacturing equipment; troubleshoot issues and support, or directly resolve as appropriate.
• Ability to read and interpret documents and drawings (e.g., blueprints, manuals, wiring diagrams etc.)
• Time management skills and ability to prioritize workflow throughout the day.
• Strong verbal and written English language communication skills.

Preferred Skills

• Forklift and OSHA Training.

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 50 pounds while moving tooling, 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.

TOMZ Corporation is an Equal Opportunity Employer

We're hiring!! TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a motivated Manufacturing Engineer 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 Engineering Manager, this position will have direct responsibility for developing and implementing robust cost-effective manufacturing processes and methods, recommends and improvements to sustained production processes, methods, and controls, as well as coordinate the launch of new products into volume production. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodize processes for Medical Devices.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Support Production in reducing / eliminating equipment and tooling downtime or scrap.
• Perform tool life studies to drive efficiency and cost savings opportunities.
• Conduct Process Capability studies during manufacturing processes to support achieving objectives.
• Collaborates with cross-functional teams during the production transfer phase to establish and launch robust, mid to high volume processes.
• Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
• Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
• Develop and improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
• Develop and qualify various tools and equipment required for manufacturing processes.
• Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
• Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
• Supporting required equipment qualification and process validations (IQ, OQ and PQ).
• Troubleshoot manufacturing processes when defects occur. Leads investigations to determine root cause and implement effective containment and countermeasures.
• Train Engineering and Operations personnel as required on manufacturing processes/equipment.
• Disposition non-conforming products and develop re-work procedures.
• Leads Kaizen events and drives continuous improvement efforts.
• Performs Other duties as assigned.

Qualifications:

Education

• Minimum of a bachelor’s degree in an engineering discipline or equivalent experience

Experience

• Minimum of 5 years’ experience within a regulated industry (preferably in a Medical Device or Aerospace contract Manufacturer)

Preferred Skills/Qualifications

• Must possess a high attention to detail.
• Ability to read drawings and specifications containing GD&T
• Proficiency in SolidWorks
• Proficient in the use of Microsoft Office, and Adobe products.
• Solid knowledge of GMP and ISO 13485 regulations
• Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
• Ability to work in a fast-paced Medical Device Manufacturing environment with high output efficiency and impeccable quality standards.

Preferred Skills

• Exhibit good time management skills and ability to prioritize workflow throughout the day.
• Motivated self-starter with ability to work both independently and as part of a team.
• 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 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.

TOMZ Corporation is an Equal Opportunity Employer

TOMZ Corporation is in search of a Quality Inspector to join our team! A leader in manufacturing of devices and components for major medical device companies, TOMZ offers competitive compensation and excellent benefits. Some of 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 Department Manager, this position will have direct responsibility for the quality control functions within the Department. TOMZ manufactures parts via high precision metal machining, assembly, and anodize processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation and/or perform inspections on machined components · Perform further complex inspections on machined components utilizing methods such as comparators, CMM and/or various manual and automated techniques. Faced paced work environment.

Essential Functions

• Perform and provide training assistance for inspections on machined components, as required, utilizing conventional visual and layout inspection techniques and equipment. Ex. include microscopes, calipers, micrometers and gages.
• Execute Incoming, First Piece, FAI, In-process, and Final Inspection, as assigned.
• 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.
• Accurately review and ensure Good Document Practices (GDP) are upheld for Routers/Inspection Plans/Device History Records (DHRs) throughout the manufacturing process and in preparation for final lot release/shipment.
• 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.
• Utilize the ERP system to prioritize and support product final acceptance and shipment, as needed.
• Generate Packing Slips and Certificates of Compliance (C of C) in accordance with TOMZ and/or customer requirements.
• Support physical and/or electronic record retention.
• Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

Education

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).

Experience

• Minimum of 3-5 years’ experience in a regulated manufacturing environment.

Qualifications

• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Ability to effectively read and understand blueprints, specifications, and procedures.
• Knowledge of dimensional, visual and mechanical inspection processes.
• Strong background concerning the usage and care of mechanical measurement equipment, tools and hand-held tools including micrometers, calipers, dial indicators, height gages, pin gages, etc.
• Maintains accuracy and attention to detail at all times and completes tasks in a timely manner.
• “Hands-on” self-starter with ability to work both independently and as part of a team.
• Strong verbal and written English language communication skills.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required, accomplishing results with minimal guidance.

Preferred Skills

• Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
• Class I, II and/or III Medical Device manufacturing experience.
• Knowledge of and experience with GMP/ISO standards.

Join our TOMZ family in Connecticut! We are looking for an Engineering Manager. Apply today or share this post with your network.

The ideal candidate will be responsible for managing and inspiring his or her team to achieve their performance metrics. Manages all engineering activities within a department including New Product Introduction, Sustaining and Continuous Improvement engineering activities. Manages subordinate staff in the day-to-day performance of their duties. Identifies and solves performance/operational issues to improve development efficiency. Leads and develops the Engineering team in support of business goals and objectives.

Your role will involve strategizing, project management, part staff management. Your collaborative attitude and interpersonal skills will help you thrive as an Engineering Manager.

Summary of Position

Reporting to the VP of Engineering, this position manages all engineering activities within a department including New Product Introduction, Sustaining and Continuous Improvement engineering activities. Manages subordinate staff in the day-to-day performance of their duties. Identifies and solves performance/operational issues to improve development efficiency. Leads and develops the Engineering team in support of business goals and objectives.

Essential Functions

• Lead ME representative on projects. Provide input on resources needed and project planning.
• Attends and arranges project meetings to discuss current and future development initiatives.
• Assists with preparation of proposals and quotations; interface as needed to resolve questions in a timely manner.
• Provide guidance and direction to coworkers on areas of technical expertise.
• Lead staff from a servant leadership perspective.
• Support and or lead as needed process capability studies during manufacturing process.
• Manage establishing and maintaining effective manufacturing processes, methods and controls for meeting safety, quality and cost objectives.
• Manage engineering change orders and coordinate the deployment of changes including training operation team members.
• Support Programmers in fixture design for manufacturing process and quality inspection departments.
• Manage Engineering system such as but not limited to BOM’s, Item Masters, Rev Control and Work Instructions.
• Supports equipment qualification and process validations (IQ, OQ and PQ).
• Drives continuous improvement efforts and lean initiatives.
• Responsible for the following project inputs: equipment selection, process development and documentation, operator training, process validation, manufacturing transfer and support of existing product lines as applicable.
• Able to work as a team member with other leaders in the organization.
• Enforce work rules and administer disciplinary action when necessary.
• Other duties as assigned.

Qualifications:

Education

• Bachelor’s Degree preferred, Engineering management, technical management, or business administration.
• 5-10 years’ experience in Engineering, preferably in Medical Device Manufacturing or equivalent.

Qualifications

• Proven leadership and supervisory skills managing a team. Ability to work fast paced and under pressure to meet customer and staff needs.
• Demonstrated critical thinking skills and willingness/ability to have difficult conversations.
• Ability to collaborate effectively with others.
• Excellent written and verbal communication skills
• Ability to train new engineering employees on project engineering activities and policies/procedures.
• Must be able to fully interpret technical drawings, blueprints, specifications and illustrations.
• Technical report preparation and formal presentation skills.
• Knowledge of Microsoft Office suite and MS Project, as well as Engineering programs such as Mastercam, ESPIRIT, etc.
• Willingness to travel if required.

TOMZ is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and is certified to ISO 13485.

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a highly motivated and driven CMM Programmer to join our organization. TOMZ offers competitive compensation and excellent benefits, including 401k, health/dental, vision and paid time off. TOMZ maintains a modem, 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 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will be responsible for developing, maintaining and generating CMM and other advanced metrology programs used to inspect and verify production materials and components. Designs, develops and procures work holding and functional gages. Reviews drawings and specifications to establish correct inspection criteria following best practices. Subject matter expertise in programming languages such as Calypso (preferred) or PC-DMIS as well as GD&T and other relevant ANSI/ASME, or ISO standards.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Develops, verifies, and operates automated inspection programs for first piece, in-process, and final inspections.
• Proves out programs limiting risk of measurement bias, linearity, reproducibility and reproducibility errors.
• Understands Alpha and Beta measurement risks and provides appropriate feedback.
• Maintains automated inspection machines to include probe qualifications, regular cleaning, and inspection of scales.
• Design and procures fixtures needed to hold products for inspection during product development; sets criteria for instruments and specifications.
• Supports automatic data collection from measurement equipment to the inspection plans.
• Supports the development of inspection methods, tool mapping, First Article Inspections (FAI's), and in process checks for manufacturing.
• Revises inspection programs and documents based on engineering changes, as required.
• Supports root cause investigation as applicable to automated inspection function, tooling, and programs.
• Contributes to process improvement; continually optimizes the inspection process by identifying bottlenecks and cost/time saving opportunities.
• Develops work instruction and conducts training of designated automated inspection equipment operators.
• Other duties and responsibilities as assigned.

Qualifications:

Education

• Technical Training in:
  • Drafting / GD&T
  • CMM programming
  • CAD modeling
  • Vision System programming

Experience

• Minimum of 7 years of direct experience working with advanced metrology equipment.

Qualifications

• Advanced knowledge of and the ability to read geometric dimensions and tolerances ASME Y14.5.
• Detailed knowledge of precision measuring instruments and their application, including but not be limited to, CMMs, Vision Systems, and Contracers.
• Strong verbal and written English language communication skills.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint), Adobe PDF,
• Expertise in 3D modeling and drafting
• Experience with Calypso CMM or Open DMIS software
• Hands-on" self-starter with ability to work both independently and as part of a team. Track record of project completion.
• Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
• Job may require up to 10% travel.

Preferred Qualifications

• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge of and experience with GMP/ISO standards.
• Experience with CT scanning, White Light and 3D metrology
• Experience with PC DMIS or Geomeasure
• Associate’s degree preferred or equivalent directly- transferrable work experience (Manufacturing or Engineering discipline preferred).

Travel Requirements

• Travel outside of the workplace is possible for up to 10% of the year.
• Flexibility is needed for last-minute emergencies.
• Travel may include multiple overnight stays and may occasionally require weekend commitments.

Physical Requirements

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.

TOMZ is an Equal Opportunity Employer

TOMZ Corporation, a leader in manufacturing of devices and components for major medical device companies, is looking for a Metrology Specialist 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 Medical Device Manufacturer and is certified to ISO 13485.

Summary of Position

This position will be responsible for the activities associated with developing advanced metrology methods in a medical device manufacturing environment. This includes but is not limited to assessing process risk and implementing appropriate control mechanisms, corrective / preventative action, and creating and refining test methods.

Essential Functions

• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Operates and programs advanced measurement equipment including Vision Systems, CMMs, PLCs, Optical Sensors, Contracers and Laser Measurement Systems.
• Acts as the Subject Matter Expert in GD&T
• Uses expertise in bench layouts to resolve complex measurement challenges.
• Collaborates and defines Test Method.
• Expertise of precision measuring instruments and their application, including but not limited to, Electronic height gages, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
• Execution and evaluation of Test Method Validations.
• Support the creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Design, Model and Build inspection work holding fixtures.
• Provides hands on direction for executing Incoming, In-Process and Final Product Inspection plans.
• Champion First Article Inspections.
• Support Gage calibration review, management, execution, and evaluation.
• Establish standards for Gage Calibration.
• Competency with materials testing chemistry and mechanical testing.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
• Reviews ECOs for the release of Quality Engineering documentation.
• Creates inspection instructions.
• Must be knowledgeable of, and adhere to, the TOMZ Quality Management System.
• Other duties and responsibilities as assigned.

Qualifications:

Education/Experience

• High School Diploma or GED
• 3+ years of technical training in GD&T and measurement programing system.
• Minimum of 0-4 years’ experience in a regulated manufacturing environment.
• Minimum of 3 years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming.

Qualifications

• Ability to travel up to 5%.
• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint)
• Strong verbal and written English language communication skills.
• Basic understanding of statistical techniques and sampling strategies

Preferred Skills

• ASQ-CQT, CQE or CRE preferred.
• Certifications in DMIS programming preferred
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).

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.