Manufacturing Engineer Technician

POSITION SUMMARY

Provide guidance and ensure compliance with the Quality System Regulations including FDA, ISO 13485, and applicable international regulations.  Develops and implements Improve/maintain the preventive maintenance activities of manufacturing capabilities at CP Medical, with a focus on equipment, fixtures, and process documentation. The job scope includes project management for new equipment/fixtures, process improvement on current equipment/fixtures, and database maintenance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Maximize equipment uptime including troubleshooting, maintenance, and repair.
  • Evaluate equipment needs, and manage the acquisition of new equipment, including research, justification, acquisition, testing, runoff, installation, documentation, and training.
  • Develop and build custom equipment and fixtures, working with suppliers and shops.
  • Manage the preventative maintenance system for equipment and fixtures; coordinate with outside service providers as needed. Manage associated maintenance records and schedule. Maintain spare parts inventory.
  • Implement documentation for new product setup (BO Ms, item masters, routings, etc.) and maintain engineering data of current records.
  • Write and execute validations for production processes, equipment, and fixtures.
  • Maintain technical knowledge and skills by activities such as attending workshops, visiting other manufacturing and equipment sites, reading technical publications.

ORGANIZATIONAL RELATIONSHIPS

LOCATION: CP Medical
DEPARTMENT: Production
REPORTS TO: Manufacturing Engineer
SUPERVISES: No Direct Reports

POSITION REQUIREMENTS

EDUCATION:

  • High School Diploma or Associate degree in an engineering technology or related field preferred.

EXPERIENCE:

  • Minimum of2-4 years or more related experience and/or training
  • Experience in medical device or food industry desired but not required

KNOWLEDGE/SKILLS/ABILITIES:

  • Proficiency in equipment and machinery troubleshooting and repair
  • Electro/mechanical background
  • Proficiency on computers and Microsoft Office, prior experience with ERP systems a plus.
  • Proficiency in reading engineering drawings, drafting skills (3D modeling) using AutoCAD or Solid Works desirable.
  • Ability to work overtime as work load dictates.

WORK ENVIRONMENT

The job is typically performed under comfortable working conditions in an office, warehouse or clean room environment where light manufacturing is performed; any disagreeable elements are generally absent during normal performance of job. Works with production equipment and machinery with moving parts.

CONFIDENTIALITY

This position has access to or may be exposed to confidential and propriety Company information.  Therefore, a high level of confidentially must be maintained at all times with any This position has access to or may be exposed to confidential and propriety Company information. Therefore, a high level of confidentially must be maintained at all times with any Company information.

LIMITATIONS AND DISCLAIMER

The above position description is meant to describe the general nature and level of work being performed; the position description is not a comprehensive or exhaustive list of all The above position description is meant to describe the general nature and level of work being performed; the position description is not a comprehensive or exhaustive list of all duties, responsibilities of skills required for the position. Management has the right to assign or reassign duties and responsibilities to or from this position at any time.

To perform this position successfully, the employee must be able to satisfactorily perform each essential position duty and responsibility. All position requirements are subject to possible modification to reasonably accommodate individuals with disabilities.

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