Machine Operator - Medical Device in San Francisco Bay Area at APEX Systems

Date Posted: 10/19/2019

Job Snapshot

Job Description

Job #:  981128
Our Client is a cutting edge manufacturer of high quality Class III medical devices.
Machine Operators operate assigned automated extrusion machinery, ensure component flow, troubleshoot and correct machinery or equipment issues to ensure quality and productivity. They perform changeovers and setups according to production schedule, perform quality checks according to established processes and document the results as required by our quality procedures. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following  EH&S policies and procedures. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).
  • Sets up, adjusts and operates extrusion machines to run various materials and sizes
  • Harrell, Davis Standard and American Kuhne lines with Melt Pumps.
  • Load materials into extruder and adjust feed mechanisms to set feed rates
  • Observe machine operations, control boards and gauges to detect any defective material or any machine malfunctions
  • Perform troubleshoot and make adjustments to maintain a high level of quality
  • Modify and/or change tooling to establish new size products (single, multi-lumen, bump, etc.)
  • Establish processing parameters for new products
  • Assist and perform IQ, OQ, PQ, etc.
  • Train new and existing operators on all processes and paperwork when needed.
  • Observes and check finished product coming off the production lines and if detects sub-standard product takes immediate corrective action
  • Responsible for ensuring continuous operations by monitoring and inspecting and re-adjusting parameters of control boards, gauges of extrusion machine
  • Ability to multi-task by running and preparing for next orders
  • Responsible for in-process and final inspection of tubing to ensure that QIP specifications are met and that product is processed to print requirements.
  • Responsible for performing routine Preventative Maintenance on machines.
  • Responsible for preparing finished parts to be taken by Material Handling.
  • Eagerly train and mentor others.
  • Accurately records information on Extrusion Data History Records, Quality Documents and Lab Notebooks
  • Follows verbal and written instruction and is accountable for his/her actions.
  • Adheres to the safety and quality standards (goals and metrics) of the organization while working within a team environment.
  • Promotes job and process improvement as it relates to the department (through 5S as well as other improvement initiatives).
  • Responds to multiple assignments in a timely and efficient manner.

  • AA Degree or equivalent work experience in related discipline and 3-5 years of related experience in the medical device industry
  • Working knowledge of engineering principles and ability to read and comprehend work instructions, schematics and design documentation
  • Proficiency with Microsoft desktop environment: Windows, Word, Excel, and Outlook
  • Strong written and verbal communication skills
  • Excellent planning and organizational skills.
  • Previous experience of working on machinery and with completing equipment maintenance required.
  • Previous exposure to automation is also required, with knowledge of pneumatic systems, mechanical motion systems & electrical drive systems.
  • Should have knowledge of operating, debugging and maintaining automated systems.

COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies:
  • Values: Integrity, Accountability, Teamwork, Innovation
  • Demonstrate a quality culture within the team, ensuring that procedures and work methods for the area are accurate and fully complied to.
  • Willing to be flexible and accommodating to meet the business need across shifts, while open to learning, and training in new processes as required.
  • Be innovative in line with lean thinking and process excellence
  • Critical thinking, troubleshooting and problem-solving ability
  • Ability to work independently
  • Demonstrated ability to work in a team and possess a positive communication style.
  • Strong mechanical aptitude and mental patience to be a hands-on problem solver is required.
  • Must be able to use a microscope and/or comparator for part inspection and be able to demonstrate print reading skills, use of calipers, micrometers, and comparators.

PHYSICAL DEMANDS AND WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Physical Activity - Repetitive motions: Must be able to constantly make substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Must be able to frequently work while extending hands and arms between knees & shoulders and handle / grasp parts with hands Talking: Expressing or exchanging ideas by means of the spoken word.
  • Physical Requirements -  Must be able to constantly remain in a stationary position such as standing or sitting. Occasionally needs to move between cleanrooms, labs or site to access equipment and work stations. Occasionally needs to walk, climb (stairs/ladders) exert up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Must be able to lift and carry a minimum weight of 50 lbs
  • Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes. 

  • Working Conditions - The performance of this position will routinely require exposure to the manufacturing areas and development labs, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing protection.

This position may require occasional travel.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.