Big Lake, MN
Posted 7 days ago

Summary of Position

Reporting to the Production Supervisor, this position will have direct responsibility for the output, efficiency for the processing of components and operators in the department on their shift. 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, setup and operate equipment, perform visual and dimensional inspections, and support development of machined components.

Essential Functions

  • Must be knowledgeable of and adhere to the TOMZ Quality Management System.
  • In the absence of a supervisor, help coordinate daily production schedules within area and drive solutions for other issues that directly impact production
  • Verify that production processes and procedures are being performed adequately and effectively.
  • Responsible to use tools provided (Next Op, Cell Board, Scheduling Board) to ensure cell output meets or exceeds expectations set by management/scheduling
    • Ensure the right equipment is running
    • Ensure the equipment is running at or better than rate
    • Ensure employees are appropriately assigned to machines according to skill level
  • Work with support members to ensure that material, tooling, and gages are prepared in advance for upcoming jobs
  • Ability to coordinate the execution of operational objectives within the department, i.e. low scrap rates, high efficiency and output, schedule adherence, etc.
  • Collaborate with engineering on new product development activities and legacy product/process improvements and explore/pilot/develop new technologies (tooling, equipment, processing, etc.)
  • Train/Coach standard best practices for Setup/Operation of equipment across all technical levels and ensure that employees are scheduled appropriately according to skill level and ability.
  • Support the setup and operation of equipment within a department by pulling the appropriate resources, as needed, to minimize downtime and increase output.
  • Work with supervisor and scheduling team to establish reaction/recovery plans to make up for lost production as necessary.
  • Perform visual and dimensional inspections on manufactured components, as required using microscope, micrometer, caliper, pin gages, thread gages, comparator, micro-hite, CMM, Vision system, etc.
  • Drive problem solving activities for complex machine or process issues and assign appropriate resources to the efforts and escalate issues to a supervisor when they cannot be quickly resolved within department.
  • Review product/process standards are accurate and achieved within the department
  • 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.
  • Utilize ADP payroll system to keep track of direct reports hours and PTO
  • Must maintain safe working conditions and follow occupational Safety and Health requirements including Personal Protective Equipment guidance and rules.
  • Set-up and run equipment as needed to support production goals.
  • Other duties and responsibilities 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 strongly preferred.

Experience

  • Minimum of 4-6 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.)
  • Demonstrated coaching or training skills to drive departmental and company objectives.
  • Knowledge of and experience with GMP/ISO standards.
  • Advanced understanding of the usage and care of mechanical equipment and inspection processes.
  • Ability to use hand-held tools to perform preventive maintenance or repair 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.
  • Strong verbal and written English language communication skills.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA as required, accomplishing results with minimal guidance.

Pay Range: $30 – $48 an hour