Manufacturing Engineer I/II

Position Summary

The Manufacturing Engineer is responsible for establishing and managing medical device manufacturing operations, with primary responsibility for production equipment setup and maintenance, cleanroom operations, and inventory control. This role ensures manufacturing processes are efficient, compliant, and scalable while maintaining strict adherence to FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and GMP standards, along with Quality Department.

This is a high-ownership role in a small, fast-paced contract design and manufacturing company. The ideal candidate is equally comfortable developing processes, building product, writing documentation, and troubleshooting issues in real time.

Key Responsibilities

Equipment & Manufacturing Setup

• Lead installation, commissioning, and qualification of manufacturing equipment (IQ/OQ/PQ)
• Support development and implementation of preventive maintenance programs
• Troubleshoot equipment issues and minimize production downtime
• Support process validation and ensure manufacturing readiness for new products
• Partner with Engineering on equipment selection, layout, and facility planning
• Maintain calibration schedules and ensure compliance with documentation requirements
• Design fixtures and troubleshoot issues

Cleanroom Operations Management

• Establish and maintain ISO 8 cleanroom operations (layout, flow, monitoring, gowning)
• Develop and maintain cleanroom procedures and standards
• Oversee daily operations of ISO-classified cleanroom environments
• Ensure compliance with cleanroom protocols, gowning procedures, and contamination controls
• Monitor environmental conditions (particulate counts, temperature, humidity, pressure differentials)
• Coordinate cleanroom certifications, environmental monitoring, and audits
• Train and enforce personnel adherence to cleanroom standards and GMP practices
• Manage cleaning validation and sanitation procedures

Inventory & Materials Management

• Establish and manage inventory control systems for raw materials, WIP, and finished goods
• Oversee material receiving, inspection, labeling, and traceability
• Ensure compliance with lot control and device history record (DHR) requirements
• Monitor inventory turns, safety stock levels, and obsolescence risk
• Manage cycle counts and physical inventory audits
• Ensure material traceability and lot control in accordance with Device History Record (DHR) requirements
• Support development of inventory tracking systems

Process Development & Pilot Builds

• Define and execute manufacturing processes through hands-on builds
• Identify process gaps and implement improvements rapidly
• Lead and execute pilot builds (hands-on)
• Capture learnings and drive improvements

Regulatory & Quality Compliance

• Ensure compliance with applicable standards and company SOPs/Quality procedures. 
• Maintain documentation for equipment validation, cleanroom monitoring, and inventory traceability
• Partner with Quality on nonconformances, CAPA, and process improvements

Qualifications

·      Bachelor’s in Engineering

·      3–5 years experience

·      Regulated environment experience

·      Hands-on skills

·      Demonstrated ability to independently drive projects from concept to implementation

·      Experience working with external vendors or suppliers

·      Ability to manage multiple parallel tasks and follow-ups effectively

Preferred:

·      Medical device / ISO 13485

·      Cleanroom experience

·      Design controls / risk management

·      CAD (SolidWorks)