RCI-BDX-3256 Product Development Engineer (SolidWorks/NPD/CAD/Tech Transfer)

On site 5 days a week .

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)

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.

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