LL01-251009 Sr Engineer for Medical Devices Job at Validation & Engineering Group, Puerto Rico

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  • Validation & Engineering Group
  • Puerto Rico

Job Description

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Sr. Engineer for Medical Devices

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 Usage Requirements Specifications and Factory Acceptance Tests
  • 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
  • Designs / Coordinates Facilities Modifications
  • Creates / Coordinates Manufacturing Line Layout
  • Develops Manufacturing Capacity Analysis
  • Designs Equipment and Tooling
  • Develops and Executes Process Characterizations / Design of Experiments (DOE)
  • Develops and Maintains Project Timeline / Plan
  • 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
  • SolidWorks Proficiency

Additional Desirable Qualifications Skills and Knowledge:

  • Engineering Post Graduate Degree (Masters / PhD)
  • 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
    • Packaging Validation
    • 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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