Job Title: Manufacturing Technician – Disposables
Reports To: Manufacturing Manager – Disposables
FLSA Status: Non-Exempt
Department: Operations


Summary: Provides technical support in development of assembly and packaging equipment and processes for medical device manufacturing. Executes sequenced procedures in all aspects of assembly, testing and final packaging, including verifying component part numbers.

Essential Duties and Responsibilities include the following.  Other duties may be assigned.

  • Responsible for supporting assembly and test processes and equipment for the manufacturing of disposable device.
  • Responsible for determining the status and disposition of product and working with various groups to resolve quality issues related to product.
  • Support Manufacturing and Quality in assembly and/or inspection of plastic components.
  • Provide support to avoid or minimize downtime and ensure proper operation and maintenance of equipment.
  • Recommend and implement changes to and/or modify fixturing and equipment to improve performance.
  • Construct, troubleshoot, adjust, test, and maintain equipment, components, devices, or systems. Work from schematics, engineering drawings, and written or verbal instructions. Operate related equipment; conducts tests and reports data in prescribed format.
  • Use predetermined methods, sequences, and setups to inspect or test specific equipment or product, making modifications and adjustments as necessary.
  • Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations.
  • Apply common sense understanding to carry out instructions furnished in written, oral or diagram form. 

Knowledge, Skill and Competency Requirements:

To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

  • Must have excellent mechanical skills, knowledge in the use of mechanical tools and measuring equipment, and the ability to understand product and tool drawings.
  • Must possess good working knowledge of automated systems and pneumatic tooling.
  • Must be able to pay attention to details and processes, good organizational, interpersonal, verbal and written skills.
  • Knowledge of ESD requirements and usage
  • Knowledge of FDA Good Manufacturing Practices, ISO 13485-2003
  • Ability to maintain a record of the assembly process, progress, and problems

Education/Experience:

  • High school graduate or equivalent
  • Minimum three years prior experience in an assembly environment

Managerial Responsibilities:
This job has no managerial responsibilities.

Physical Demands:

  • Physical requirements include lifting 18-25 lbs. and disassembling instruments using hand tools. 
  • Execute daily tasks in a controlled environment room.

Required Training:

The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure. The employee shall also receive general training in both 21CFR 820 and EN13485 as well as the OptiScan Quality Manual and Quality Policy.

This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

 

If you are interested in applying to an open position at OptiScan, please email your resume to [email protected]