Product Development Engineer - Urgent Need

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.

• Captures and coordinates suppliers for manufacturing of custom equipment/tooling
• Captures and coordinates purchase and delivery of equipment/tooling
• Captures and 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)
• Generates documentation/justification for assigned capital projects
• Complies with cGMP’s, Quality Standards, and established policies and procedures
• Executes other duties assigned by his supervisor

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

• Leverage 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