Manufacturing Engineer Job at NextGen IT Labs in Warsaw

Overview

Manufacturing Engineer – Warsaw, IN (Onsite). Contract role (W2).

OPT will work

Responsibilities

• Experience supporting medical device manufacturing process validations, including process characterization, equipment IQ/OQ, process OQ, and PQ.
• Experience with Test Method Validation and Gage R&R.
• Root cause analysis and problem solving for technical and process issues.
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485:2003.
• Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
• Apply quality and statistical tools for problem solving.
• BOM and Router creation and updates.
• Ability to read and understand engineering drawings.
• Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), and Critical-to-Quality (CTQ) Analysis. Knowledge of Quality System requirements, ISO and FDA requirements.
• Effectively work within a cross-functional team to complete critical project tasks.
• Demonstrates good written and verbal communication skills.
• Experience with control procedures, such as Change Management System, Nonconformance Reports, Engineering Specifications, CAPA, and Work Instructions; proficient with Statistical Process Control concepts; Microsoft Office Suite and Project.
• 4-6 years of relevant experience.
• Develops and executes process validation strategies: creates plans, protocols (IQ/OQ/PQ), and risk assessments to ensure effective processes for medical devices and equipment.
• Ensures regulatory compliance: adheres to FDA 21 CFR 820, ISO 13485, and other relevant regulations, participates in audits, and maintains up-to-date knowledge.
• Analyzes data and reports findings: compiles and analyzes validation data, writes comprehensive reports, identifies trends for process improvement.
• Collaborates cross-functionally with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support.
• Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training.
• Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.
• Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.
• Conducting feasibility studies to estimate product cost.

Qualifications

• 4-6 years of experience in manufacturing engineering or related field.
• On-site work in Warsaw, IN.