Job Description

Job Description

** Job Title: Product Development Engineer 3 / GIE EPI Engineer 3**
** Job Id: 26-01872**
** Location: El Paso, TX**
** Duration: 12 Months Contract**
** Position Type: Hourly Contract Position (W2 only)**

• GIE EPI Contractor Engineer 3
• On site 5 days a week.
• Education bachelor's degree

** Summary of Position with General Responsibilities:**

• Leads technical support to new product transfers and/or product development projects.
• Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.

** Technical Skills**
Must Have

• Risk Management: Experience with FMEA (Failure Mode and Effects Analysis)
• Technical Documentation: Experience developing SOPs, validation protocols and process documentation
• understanding Geometric Dimensioning and Tolerancing (GD&T)
• Validation Protocols: Development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

** Nice To Have**

• CAD/CAM software (SolidWorks, AutoCAD)

** Essential Job Functions:**

• Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling
• Coordinates purchase and delivery of Equipment/Tooling
• Coordinates installation of Equipment/Tooling
• Develops and Executes IQ and OQ Protocols and Reports
• Develops and Executes Test Method Validations / Gage R&R
• Generates and Issues for Approval SOPs and Manufacturing Procedures
• Develops and Executes Component Qualifications
• Develops and Executes PQ and PPQ Protocols and Reports
• Develops Manufacturing Capacity Analysis
• Develops and Executes Process Characterizations / Design of Experiments (DOE)
• Develops documentation/justification for assigned capital projects
• Complies with cGMP's, Quality Standards , and established policies and procedures
• Executes other duties assigned by his supervisor

** Basic Qualifications:**

• Bilingual - English and Spanish (oral and written)
• Technical writing skills
• GMP, ISO, EHS and Statistical regulations knowledge
• Strong Computer Skills/Knowledge (Word, Excel, PowerPoint)
• MS Project knowledge
• Minitab Proficiency

** Additional Desirable Qualifications Skills and Knowledge:**

• Lean / Six sigma Training/Certification
• Project Management Training/Certification
• Engineering Board Certification (EIT / PE)

** Education and/or Experience:**

• Bachelor's Degree in Engineering
• Experience in the Medical Device / Pharmaceutical Industries: Yes
• 5+ years of experience in the following fields:
• Manufacturing
• New Product Transfers
• Product / Process Development

** Job Functions Experience in the following:**

• Qualification / Validation (IQ/OQ/PQ)
• Test Method Validation / Gage R&R
• Process Characterization / Design of Experiments (DOE)
• Manufacturing Line Design / Capacity Analysis
• Equipment / Tooling Design
• Equipment Installation / Preventive Maintenance Procedure Generation
• Root Cause Analysis / Investigation
• SOP / Manufacturing Procedures Generation & Change Control
• Product Financials & Supply Chain Structure Design
• OEE Integration, Vertical Start up and Zero-loss mindset

** Qualified candidates please send your word format updated resume at the earliest to Pavan: Pavan.p@sunrisesys.com [732-395-4444].**

Thank You

Company Description

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

Company Description

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.