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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.
• Additional requirements as outlined in full job description.

Qualifications:

Education/Experience

• 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).

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.
• Additional responsibilities as outlined in full job description.

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.

Preferred Skills/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.
• Additional qualification as outlined in full job description.

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.
• Additional responsibilities as outlined in full job description.

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.

Preferred Skills/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.
• Additional qualification as outlined in full job description.

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).

Experience

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

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.

Summary of Position

Reporting to the Operations Leader, this position will have responsibility of manufacturing with assistants through various basic functions within the Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation. The following tasks may be completed with assistance operating equipment and perform visual and dimensional inspections on machine components.

Essential Functions

• With assistance, Operate and maintain Citizen Lathes, Tsugami Lathes and/or 3-4-5 axis production equipment, including Robo Drills and horizontal/vertical mills.
• With assistance, perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, Micro-Hite, etc.
• Complete and compile necessary documentation related to Quality Inspection standards.
• Learn and support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
• Must maintain safe working conditions and 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

Qualifications

• Operator experience with CNC machines or other equipment in a production environment
• Strong math background, preferable in machine math/shop math
• Willingness to learn and grow in the manufacturing industry as an entry level position.
• Ability to use basic hand-held tools to perform preventive maintenance activities.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.

Preferred Skills

• Prior experience in one of the following areas: assembly of medical instruments, prior experience operating equipment in a production setting or part handling.
• Prior experience working in a regulated manufacturing environment.
• Ability to read and understand a Blueprint.
• Ability to operate a microscope.
• Ability to read measurement equipment such as micrometer, caliper, pressure micrometer
• Strong verbal and written English language communication skills.

Physical Demands

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
• Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
• 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Ability to sit or stand for prolonged periods.

Summary of Position

Reporting to the Facilities Manager, this Facilities Assistant 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).

Experience

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

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.

Summary of Position

Reporting to the Supply Chain Manager, this position is responsible for supporting operations with product flow as needed. 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 issuance 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.
• 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 Demands

• 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.

Summary of Position

Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within the Swiss machining department. TOMZ manufactures parts via high- precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components using various precision measuring equipment.

Essential Functions

• Set up and operate and maintain Citizen Lathes or Tsugami Lathes.
• Perform offsets and tool changes to ensure efficient production with minimal support.
• Set up complex legacy components and new production orders for steady machine operation.
• Perform preventative maintenance on Swiss Lathe to ensure consistent machine performance
• Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
• Perform scheduled and regular preventive maintenance on equipment.
• Drive problem-solving activities for complex machine or process issues.
• Complete and compile documentation related to quality inspection standards.
• Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
• Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
• Capable of mentoring and training lower-level machinists.
• Facilitate a continuous improvement in culture and ensure quality and delivery objectives are met.
• Utilize ERP and QMS systems to document and control inspection and traceability activities.
• Maintain safe working conditions and follow occupational safety and health requirements, including PPE guidance.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

Education

• Certification from a technical school program or equivalent, directly transferable work experience in a manufacturing or engineering discipline may be accepted.
• Certification from a technical school program is strongly preferred.

Experience

• Minimum of 3-7 years’ experience in a regulated manufacturing environment.

Qualifications

• Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
• Strong math background, preferable in machine math/shop math
• Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
• Knowledge of and experience with GMP/ISO standards.
• A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results with minimal guidance.
• Advanced understanding of mechanical equipment usage, care, and inspection processes.
• Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
• Skilled in reading and understanding of blueprints, specifications, and procedures.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
• Proficient in identifying nonconformances and maintaining organization.
• Intermediate skills in GD&T.

Preferred Skills

• Strong verbal and written English language communication skills.

Physical Demands

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
• Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
• 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Ability to sit or stand for prolonged periods.

Summary of Position

Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within a machining Department. TOMZ manufactures parts via high- precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components using various precision measuring equipment.

Essential Functions

• Set up and operate and maintain Citizen Lathes or Tsugami Lathes
• Perform offsets and tool changes to ensure efficient production with minimal support.
• Set up legacy components and new production orders for steady machine operation.
• Perform preventative maintenance on Swiss Lathe to ensure consistent machine performance
• Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
• Perform scheduled and regular preventive maintenance on equipment.
• Drive problem-solving activities for complex machine or process issues.
• Complete and compile documentation related to quality inspection standards.
• Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
• Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
• Utilize ERP and QMS systems to document and control inspection and traceability activities.
• Maintain safe working conditions and follow occupational safety and health requirements, including PPE guidance.
• 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).
• Certification from a technical school program preferred.

Experience

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

Qualifications

• Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
• Strong math background, preferable in machine math/shop math
• Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
• Knowledge of and experience with GMP/ISO standards.
• A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results with guidance.
• Understanding of mechanical equipment usage, care, and inspection processes.
• Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
• Effectively read and understand blueprints, specifications and procedures.
• Understanding of GD&T.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
• Identify nonconformances and maintain organization.

Preferred Skills

• Strong verbal and written English language communication skills.

Physical Demands

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
• Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
• 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Ability to sit or stand for prolonged periods

Summary of Position

Reporting to the Operations Supervisor, this position will have direct responsibility for the set-up and manufacture of components within the Swiss machining department. TOMZ manufactures parts via high- precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, set up and operate equipment, and perform visual and dimensional inspections on machined components using various precision measuring equipment.

Essential Functions

• Set up and operate and maintain INDEX multi-spindle lathes.
• Perform offsets and tool changes to ensure efficient production with minimal support.
• Set up complex legacy components and new production orders for steady machine operation.
• Perform preventative maintenance on INDEX to ensure consistent machine performance
• Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
• Perform scheduled and regular preventive maintenance on equipment.
• Drive problem-solving activities for complex machine or process issues.
• Complete and compile documentation related to quality inspection standards.
• Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
• Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
• Capable of mentoring and training lower-level machinists.
• Facilitate a continuous improvement in culture and ensure quality and delivery objectives are met.
• Utilize ERP and QMS systems to document and control inspection and traceability activities.
• Maintain safe working conditions and follow occupational safety and health requirements, including PPE guidance.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

Education

• Certification from a technical school program or equivalent, directly transferable work experience in a manufacturing or engineering discipline may be accepted.
• Certification from a technical school program is strongly preferred.

Experience

• Minimum of 3-7 years’ experience in a regulated manufacturing environment.

Qualifications

• Experience in Class I, II, and/or III medical device manufacturing within a regulated environment using calibrated equipment and hazardous materials.
• Strong math background, preferable in machine math/shop math
• Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
• Knowledge of and experience with GMP/ISO standards.
• A self-starter capable of working independently and as part of a team, with the ability to collaborate across various functional areas, including R&D, Manufacturing, and QA, to achieve results with minimal guidance.
• Advanced understanding of mechanical equipment usage, care, and inspection processes.
• Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
• Skilled in reading and understanding of blueprints, specifications, and procedures.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
• Proficient in identifying nonconformances and maintaining organization.
• Intermediate skills in GD&T.

Preferred Skills

• Strong verbal and written English language communication skills.

Physical Demands

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
• Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
• 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Ability to sit or stand for prolonged periods.