Validation & Engineering Group, Inc. · 3 months ago
LL01-251009 Sr Engineer for Medical Devices
00741, PR, US
Full-time
Onsite
Senior Level
5+ years expValidation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Medical Devices. They are seeking a Sr. Engineer for Medical Devices who will lead technical support for product transfers and development projects, ensuring compliance with quality standards and managing equipment/tooling processes.
BiotechnologyConsultingProfessional ServicesQuality Assurance
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 cGMP’s, Quality Standards, and established policies and procedures
Executes other duties assigned by his supervisor
Qualification
Required
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
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
Preferred
Engineering Post Graduate Degree (Masters / PhD)
Lean / Six sigma Training/Certification
Project Management Training/Certification
Engineering Board Certification (EIT / PE)
Company
Validation & Engineering Group, Inc.
Validation & Engineering Group, Proudly serving our clients since 1997.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-06Acquired
Leadership Team
Luis Puig
Partner
Recent News
News is my Business
2025-08-20
Company data provided by crunchbase