Manufacturing Engineer II

Peninsula, CA

Posted: 08/15/2018 Employment Type: Direct Hire Industry: Medical Device Job Number: JOS000007964

Manufacturing Engineer II

 

Reports to: Sr. Mfg. Mgr.; Sr. Mfg. Eng. Mgr.

 

Department: Manufacturing

 

Original Issue Date: May 10, 2018

 

Revision Date:

 

FLSA Status: Exempt

 

 

PURPOSE OF JOB: Support the manufacturing operation to improve yield and product quality. Ensure the operation remains in compliance. Interface with other Quality and R&D to achieve project goals.

 

MAJOR DUTIES AND RESPONSIBILITIES:

  • Works daily with assemblers and production staff to improve training and processes

  • Initiates and completes technical activities related to product or process improvement. Prepares reports, publishes, and makes presentations to communicate findings.

  • Analyzes and solves problems using basic engineering principles on routine assignments.

  • Understands engineering principles theories, concepts, practices and techniques.

  • Cultivates internal and external network of resources to complete tasks.

  • Participates in validation activity. Role may vary between providing input to execution of validation activities.

  • Incorporates business policies and procedures into task completion.

  • Interacts cross functionally and with Quality, Regulatory Affairs and R&D.

  • Responsible for equipment procurement, calibration, installation and qualification.

  • Supports the ongoing manufacturing operation.

  • Generates and reviews manufacturing documentation such as LHRs and MPIs.

 

EDUCATION REQUIREMENTS: BS in applicable engineering discipline

 

EXPERIENCE REQUIREMENTS: Minimum of 2 years’ prior experience in a medical device, equipment or pharma manufacturing environment.

 

OTHER QUALIFICATIONS: Familiarity with combination (drug/device) products desired.

 

 

PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:

 

  • Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.

  • Sedentary work: Exerting 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. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

  • 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.

  • The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

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