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Product Development Engineer 3 / GIE EPI Engineer 3

Sunrise Systems Inc

El Paso, TX

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JOB DETAILS
SKILLS
Assembly Line, AutoCAD, Biotech and Pharmaceutical, CAD (Computer-Aided Design) Software, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Capacity Analysis, Capital Project, Change Control, Computer Skills, Current Good Manufacturing Practice (cGMP), Documentation, Engineer in Training (EIT), English Language, Experiment Design, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), Geometric Dimensioning and Tolerancing, ISO (International Organization for Standardization), Lean Six Sigma, Machine Tool, Manufacturing, Manufacturing Analysis, Medical Equipment, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Microsoft Word, Minitab, Multilingual, Policy Development, Preventative Maintenance, Procedure Development, Process Development, Process Validation, Product Development, Product Engineering, Product Support, Project Management Certification, Quality Assurance Methodology, Quality Metrics, Regulations, Risk Management, Root Cause Analysis, Six Sigma Certification, SolidWorks, Spanish Language, Standard Operating Procedures (SOP), Startup, Supply Chain, Technical Leadership, Technical Support, Technical Writing, Test Plan/Schedule, United States Department of Energy (DOE), Validation Plan, Validation Testing, Writing Skills
LOCATION
El Paso, TX
POSTED
19 days ago
Our client, a leading Medical Device Manufacturing Company is looking for Product Development Engineer 3 / GIE EPI Engineer 3 and This is for an initial duration of 12 MonthsContract – El Paso, TX
 
Job Title: Product Development Engineer 3 / GIE EPI Engineer 3
Job Id: 26-02521
Location: El Paso, TX
Duration: 12 Months Contract
Position Type: Hourly Contract Position (W2 only)
  • GIE EPI Contractor Engineer 3
  • On site 5 days a week.
  • Education bachelor's degree
Summary of Position with General Responsibilities: 
  • Leads 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.
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)
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
Qualified candidates please send your word format updated resume at the earliest to Pavan:

Pavan.p@sunrisesys.com

[732-395-4444].
 
Thank You

About the Company

S

Sunrise Systems Inc

Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.

We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.

Our collective business experience spans over two and a half decades and ranges from:

  • Business, management, and technical fields
  • Information technology consulting and software solutions.
  • Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
  • Motivating technology staff and establishing partnerships with Fortune 500 companies

Sunrise Systems has a vast range of competence in:

  • Design, development, and support of cloud-based solutions from simple to highly complexed
  • Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
  • Data processing and data migration
  • Application re-engineering and platform migration
  • Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990
WEBSITE
http://www.sunrisesys.com/

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