Product Development Engr 3/GIE EPI Contractor Engineer 3

Job Description Product Development Engr 3/GIE EPI Contractor Engineer 3

Location:

El Paso, TX 79912 (onsite)

Duration:

12

Months Job Description:

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

TECHNICAL SKILLS

Must Have:

Risk Management:

Experience with FMEA (Failure Mode and Effects Analysis)

Technical Documentation:

Experience developing SOPs, validation protocols and process documentation understanding Geometric Dimensioning and Tolerancing (GD&T)

Validation Protocols:

Development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Nice To Have:

CAD/CAM software (SolidWorks, AutoCAD) Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $37.50/hr.