Manufacturing Team Member II AccessClosure

SUMMARY/RESPONSIBILITIES:

SUMMARY:
Assembles and package components, subassemblies, and finished devices to meet specifications.
Uses hand tools, fixtures, and equipment to assist with the assembly and inspection assemblies.
Cross-trains to become proficient with the device assembly processes from start to finish.
Understands and use Quality System Requirements (QSR).
Must have good verbal and written communication skills.
Ability to identify and report any product quality problems

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Assemble subassemblies and final assemblies per written specification.
Provides feedback for improving manufacturing tools and assembly instructions.
Understands and adheres to safety policies and practices and communicates any issues related to product quality or workplace safety.
Responsible for quality and adheres to manufacturing process requirements, the Quality Policy and overall Quality Systems Regulation of the company.
Builds product by following all processes in which certified (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics.
Demonstrate a basic understanding of Lean Manufacturing and related principles.
Willing to flex and rotate as necessary. Work well with all group members both within the team and cross-functionally.
Able to use and understand basic English communication both written and spoken; demonstrate basic reading, writing and math skills.
Maintains accurate records like Lot History Records (LHR) and test records. Also helps ensure that the team is consistently maintaining records accurately.
Understand and follow all ACI policies and procedures
Responsible for attending and passing all required ACI and site-specific training (i.e. Lean Training, LHR and other basic training requirements for the job).
Supports other duties that may be assigned on an individual basis.
Must maintain an acceptable level of attendance (including Mandatory Over Time).
Maintain accurate test records (i.e. Lot History Records(LHR)). Also helps ensure that the team is consistently maintaining records accurately.
Demonstrates and applies a solid understanding of Lean Manufacturing and related principles.
Knows and applies flex strategy, rotates as necessary and works well with all group members, both within the team and cross-functionally.
Actively participates in continuous improvement teams.
Must be able to read manufacturing instructions and understand assembly drawings (including understanding tolerance and metric measurement system).
May be assign to helps train other Manufacturing Team Members (MTM) on manufacturing processes and other procedures.
Package final product per written specification

EDUCATION/EXPERIENCE:

High school diploma or equivalent work experience.
2-5 years experience in the medical device/pharmaceutical field or in a related area.
Must be able to work in a Controlled Environment Room
Must have good eye-hand coordination.
Must be able to handle small parts under a microscope.
Polymer experience is a plus.

WORK ENVIRONMENT:
Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
Work includes potential exposure to chemicals.

SUPERVISORY RESPONSIBILITIES:

No direct supervisory responsibilities.

Location:	Mountain View, CA United States