Lead Tech - Prod Setup and Mant

Summary: Perform routine and advanced repairs on equipment and assist with the calibration and preventative maintenance activities of equipment in the Manufacturing and R&D areas.

Essential Duties & Responsibilities:

• Perform routine and advanced repairs on all types of equipment (including fixtures) that includes mechanical, pneumatic, and electrical systems.
• Possess intermediate to advanced knowledge of a wide range of equipment and the ability to provide technical support to Manufacturing, R&D, and other departments.
• Able to troubleshoot automated equipment and debug software issues.
• Document new processes and create associated Work Instructions (WI) as needed.
• Ability to review results to ensure that it complies with predetermined requirements/criteria (such as visual, dimensional, etc. criteria).
• Perform routine calibration and preventative maintenance on manufacturing/R&D equipment and systems.
• Coordinate activities/schedules with service providers to ensure timely completion of repairs and/or calibration (as needed).
• Coordinate with vendors for purchasing/RTV activities.
• Responsible for adhering to all hygiene and safety standards.
• Responsible for following all company SOPs, cGMPs, WIs, and Quality policies.
• Must be able to work effectively with cross-functional personnel.
• Must be able to work independently with little to no supervision.
• Able to schedule work with department owners to ensure timely completion of all assigned activities.
• Responsible for communicating business related issues or opportunities to next management level.
• For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets.
• Performs other duties assigned as needed.

Education and Experience Requirements:

• High school diploma or equivalent work experience (AA degree or higher preferred) and 8 years related work experience required.
• 2 years working with production related equipment within a CER (Controlled Environment Room) is preferred.
• Familiarity with and ability to apply safety requirements and specified by California’s Code of Regulations, Title 8, General Industry Safety Orders, including Control of Hazardous Energy, Compressed Gas Safety and Machinery and Machine Guarding is preferred.
• Experience or training in hazardous material emergency response is desirable
• Experience in a regulated industry where documentation compliance is enforced is preferred.
• Knowledge of use of hand-tools.
• Basic proficiency with computers and basic use of the Windows operating system environment is required
• Basic knowledge using Microsoft Word, Excel, and Outlook.
• Basic written and verbal communications skills is required
• Able to speak and understand Basic English (both written and spoken).
• Lifting, pushing, pulling, moving of equipment and furniture up to 50 lbs. may be required, working at elevation (such as on ladders and roof level) may be required.

Additional Position Requirements:

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)