What are the responsibilities and job description for the Product Development Engineer 3 position at Sunrise Systems, Inc.?
Only on W2 - No C2C
Contract Duration: 12 Months Contract
Location: El Paso, TX
- 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