Product Development Engineer - Min is Req in medical device & Pharmacetuical Industry

Product Development Engineer

Location:

El Paso, TX. Duration: 12 months. Total Hours/week: 40. 1st Shift. Client:
Medical Devices Company.

Employment Type:

Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT).

Summary of Position with

General Responsibilities:

• Leads the 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.
• 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)

• 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
• Experience in the following job functions:
  • 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