What are the responsibilities and job description for the Product Development Engineer - Urgent Need position at MillenniumSoft Inc?
Position : Product Development Engineer - Urgent Need
Location : El Paso, TX
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Engineering
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Job Description
Location : El Paso, TX
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Engineering
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Job Description
- Summary of Position with General Responsibilities:
- 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.
- 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
- 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
- Lean / Six sigma Training/Certification
- Project Management Training/Certification
- Engineering Board Certification (EIT / PE)
- Bachelor’s degree in engineering
- Experience in the Medical Device / Pharmaceutical Industries: Yes
- Manufacturing
- New Product Transfers
- Product / Process Development
- 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