Senior Technician, Facilities & Equipment (2nd Shift)

Irvine · On-site$27 – $27

About this role

Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: High SchoolSalary Range: $27.00 - $27.00 HourlyJob Title: Senior Technician, Facilities & Equipment

Role Level: Individual Contributor

Supervisor/Manager Title: Manager, Facilities

Job Location & Environment: Irvine, CA- Corporate Office / Controlled Cleanroom Environment / Warehouse

Job Description Summary: Responsible for activities related to maintaining and improving facility function. Provides support to Equipment Technician as required.

Job Responsibilities

Performs scheduled Preventative Maintenance (PMs) on Manufacturing, R&D and Facility infrastructure-related equipment and systems.
Performs unscheduled maintenance on Manufacturing, R&D and Facility infrastructure-related equipment and systems.
Receives and responds to automated electronic (text /email) equipment/system notifications and alarms after hours and weekends.
Populate, update, and maintain the Equipment Maintenance Software partnering with Equipment Tech and Quality department.
Performs equipment calibration, validation, and verification procedures, as necessary.
Adds and maintains vendors/suppliers on the company Approved Supplier List (ASL).
Cross-trained and operates within the electronic P.M and Calibration Software. Works with Quality to maintain a high degree of accuracy, timeliness, and effective completion rate.
Assembles equipment, fixtures, and tools.
Is knowledgeable of facility systems and owns the proper operation of those systems, partners with their manager, team, and vendors.
Supports all manufacturing-related aspects of cleanroom support, including – Compressed air system, RO/DI water system, Clean Room operation, HVAC, plumbing, electrical, furniture, cleaning, large equipment selection and installation, while participating with management, vendors, and cross-functional teams.
Supports all facility aspects of company department support, including selection and installation of fixtures, furniture, and equipment, while participating with cross-functional teams and individuals.
Supports production operations in accordance with work instructions, good manufacturing practices, and good documentation practices in compliance with the JenaValve quality system as required.
Supports process and controls of inventory and raw materials including cages, racking, shelving, fork-lift and environmental conditions (roof maintenance, temp control, humidity control, monitoring, etc.).
Adheres to all aspects of the JenaValve Quality Management System in the completion of their duties.

QualificationsRequired Education and Experience

High school degree minimum, Associate degree desired.
Minimum 4 years’ experience performing facility operations related functions in a highly regulated industry (Medical, Aerospace, Automotive).
Familiarity with procedures, equipment and tools used in the medical device industry or other regulated industries.

Skills and Abilities Required for This Job

Must be able to work effectively and collaborate within cross-functional teams.
Ability to follow written and verbal instructions.
Ability to take initiative and able to complete hands-on work.
Ability to focus on single tasks that require high attention to detail.
Able to prioritize multiple tasks for efficiency.
Must be able to perform routine and non-routine work with minimal supervision.
Must be able to complete the applicable training requirements.
Must understand GMP procedures and be able to work in a controlled environment (clean room) when servicing equipment.

Physical Requirements

Must be able to frequently stand, walk, bend, stoop, kneel, and climb ladders while performing maintenance and equipment support activities.
Must be able to lift, carry, push, and pull materials, tools, equipment, and supplies weighing up to 50 pounds without assistance and heavier items with appropriate equipment or assistance.
Must be able to work in a variety of environments, including office, warehouse, manufacturing, cleanroom, and mechanical equipment areas, while wearing required personal protective equipment (PPE).
Must be able to perform work in confined spaces, elevated locations, and around mechanical, electrical, and utility systems while following all applicable safety procedures.
Must possess sufficient visual acuity, manual dexterity, and hand-eye coordination to inspect, troubleshoot, repair, calibrate, and maintain equipment and facility systems.
Must be able to work 2nd shift.

Company at a glance

JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR).

The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis.

In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR.

JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.

Founded2013
Team Size51-200 employees
WorkspaceOn-site
IndustryMedical Equipment Manufacturing
Location
Irvine, California, United States
LinkedInLinkedIn

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