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

Position: Product Development Engineer - Min 4-5 Yrs Exp is Req in medical device & Pharmacetuical Industry

Job Category :
Engineering

• 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.

Position :
Product Development Engineer Location :
El Paso, TX Duration : 12 Months Total Hours/week : 40.00 pay range -$25-30/hr 1st Shift Client :
Medical Devices Company Job Category :
Engineering

Employment Type

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

Job Description

• 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.

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

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