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CNC Machinist
1 week ago
Our client is a leader in manufacturing of devices and components for major medical device companies, is looking for a CNC Machinist - Swiss Machinist to join their organization.
They offer competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. They maintain a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous process improvement. Our client is registered with the FDA as a Class 2 and Class 3 Medical Device Manufacturer and certified to ISO 13485.
The CNC Machinist will have direct responsibility for the set-up and manufacture of components within the Swiss machining department. Our client 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.
- Utilize ERP and QMS systems to document and control inspection and traceability activities.
- Facilitate a continuous improvement in culture and ensure quality and delivery objectives are met.
- Capable of mentoring and training lower-level machinists.
- Support Quality Best Practices and contribute to continuous improvement in GDP/GMP.
- Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
- Complete and compile documentation related to quality inspection standards.
- Drive problem-solving activities for complex machine or process issues.
- Perform scheduled and regular preventive maintenance on equipment.
- Conduct visual and dimensional inspections using microscopes, micrometers, calipers, pin gauges, thread gauges, comparators, Micro-Hite, CMM, and vision systems.
- Perform preventative maintenance on Swiss Lathe to ensure consistent machine performance
- Set up complex legacy components and new production orders for steady machine operation.
- Perform offsets and tool changes to ensure efficient production with minimal support.
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 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.
- Proficient in identifying nonconformances and maintaining organization.
- Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
- Skilled in reading and understanding blueprints, specifications, and procedures.
- Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
- Advanced understanding of mechanical equipment usage, care, and inspection processes.
- 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.
- Knowledge of and experience with GMP/ISO standards.
- Relevant job experience in regulated manufacturing, with industry experience in aerospace, defense, or automotive.
- Strong math background, preferable in machine math/shop math
Education:
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
- Certification from a technical school program is strongly preferred.
Experience:
- Minimum of 2-7 years experience in a regulated manufacturing environment.
Available Shifts:
- 1st - Monday - Friday 6:00am - 4:30pm
- 2nd - Monday - Friday 5:30pm - 4:00am (15% differential)
- 3rd - Friday - Sunday 6:00am - 6:00pm (20% differential plus work 36 hours and get paid for 40 hours)
- 2nd - Monday - Friday 5:30pm - 4:00am (15% differential)
Our client is an Equal Opportunity Employer
