Manufacturing Engineer - Contract

Company: Atlantic Partners
Location: Irvine
Posted on: January 24, 2023

Job Description:

Responsibilities:

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• Develops, evaluates, and improves manufacturing methods. Writes assembly procedures for new products and revises assembly procedure for existing products. Confers with Quality Engineering representative and incorporate appropriate quality checkpoints in assembly procedures.
  
• Support Design Transfer of new products from R&D to Production (including OQ/PQ) by leading and documenting Manufacturing Design Reviews, and Prototype and Pilot Builds. Writes and reviews production-related items for FMEA/Hazard Analysis. Identifies, designs and develops production and test tooling and fixtures.
  
• Provide Engineering support to CPI (Continuous Product Improvement). Screens waivers, CAPA items, material failures, etc. to identify candidates for ECO. Researches corrective action, writes Project Requests, makes clear recommendation (redlines) to drafters, and directs and supports V&V testing (including reporting) as necessary.
  
• Trains manufacturing employees on the use of all applicable manufacturing process documentation and procedures.
  
• Analyzes and plans work force utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency and FDA/OSHA compliance. Manages equipment maintenance program and writes equipment process and product validation protocols and reports.
  
• Provide Facilities support for the service, security, and maintenance of the building. Monitor health and safety risks to employees.
  
• Confers with vendors to develop product specifications and arrange for purchase of equipment, materials, or parts, and evaluates product according to specifications and quality standards. Performs IQ/OQ/PQ of equipment as required.
  
• Identifies, designs, and develops production tooling, test tooling and fixtures. Utilizes SolidWorks design software in those design efforts.
  
• Estimates production times, staffing requirements, and related costs to provide information for management decisions.
  
• Confers with management, engineering, and other staff regarding manufacturing capabilities, production schedules, and other consideration to facilitate production processes and maximize efficiency while ensuring quality.
  
  
  
  Requirements:
  
  
  
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  • BS Manufacturing Engineering/Mechanical Engineering Masters degree a plus; five plus years related experience and/or training in the medical device manufacturing industry; or equivalent combination of education and experience. Must be able to demonstrate experience in Design Transfer and writing assembly procedures for medical device production. Must be able to demonstrate project management experience.
    
  • To perform this job successfully, an individual should have knowledge of Design software (SolidWorks), Manufacturing (MRP) software, Project Management software, Statistical software, Spreadsheet software, and Word Processing software.
    
    

Keywords: Atlantic Partners, Irvine , Manufacturing Engineer - Contract, Engineering , Irvine, California