LL01-251009 Sr Engineer for Medical Devices

Validation & Engineering Group • Punta Santiago, PR

73d

About The Position

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. The position leads the technical support to new product transfers and/or product development projects, possessing technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.

Requirements

• 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
• Bachelors Degree in Engineering
• 5+ years of experience in Manufacturing, New Product Transfers, and Product / Process Development

Nice To Haves

• Engineering Post Graduate Degree (Masters / PhD)
• Lean / Six sigma Training/Certification
• Project Management Training/Certification
• Engineering Board Certification (EIT / PE)

Responsibilities

• 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 cGMPs, Quality Standards, and established policies and procedures
• Executes other duties assigned by his supervisor

What This Job Offers

• Career Level: Mid Level
• Industry: Personal and Laundry Services
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees