Job Title

LocationMFG Engineer

Warshaw, IN










                             Job Description 
(Define At least 6 points which candidate is supposed to do) Knowledge in Program development process  Familiar with Good
Documentation Practices (GDP)
 Familiar with GAMP Principles including Lifecycle V Model.
 Experience with Windows Form applicationAnd UI/UX design experience
 User Requirements Specification (URS), Functional Requirements Specification (FRS) Traceability Matrix (TM), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),
 Installation Qualification Protocol (IQP),
Operational Qualification Protocol (OCP),
Performance Qualification Protocol (PQP),
Process Validation Protocol (PV)
 SQL server database managementExperienceDrafting and formalizing Process Documentation (Manufacturing Process
 Specifications (MPS),
Job Breakdown Sheets (JBS),
 Product Inspection Criteria (PIC)
 Software Validation including but not limited to generation of software
 deliverables including Functional
 Specification, Design Specification,
Module Specification and associated testing scripts and protocols to verify requirements specified are met.
 Vision system experience- Cognex.Windchill PLM system.GD&T, SPC, cp/cpk process Capability studiesExperience in PLC, programming.21 CFR 820 medical device regulations21 CFR 830 UDI requirementsDFM principles, 2D-CAD, 3D modelsExperience, Rapid prototyping /3D printing
Experience.


KEY COMPETENCIES REQUIRED:
 High Attention to Detail                       Pro-active approach to Work
 High Standards                             FlexibleExcellent Communication Skills   Analytical Skills                 Team PlayerHigh level of Numeracy                      Computer Literate
  QUALIFICATIONS & EXPERIENCE
ESSENTIAL:        
               QMS/CAPA/PFMEA/Proficient in set-up and operation of inspection equipmentProficient in metrology methods/technologyProficient in reading/interpreting engineering drawings and the application of Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5Geometry & TrigonometryProficient in Microsoft Word & Excel.Excellent interpersonal & communication skills Knowledge of mechanical inspection methods and tools used to determine product acceptanceAbility to investigate and learn new technologies within metrology
DESIRABLE:              Certificate / Diploma / Degree in Quality / Manufacturing / Engineering21 CFR 11 and European regulations associated with the medical device industry High understanding of GMP Working knowledge of Quality Systems (FDA/ISO) within a regulated environment.Familiarity with statistical analysis software