Manufacturing Engineer

Intellectt Inc; Norfolk (NE); On-site; USD 85,000 - 110,000; Full time

Job summary

Intellectt Inc. in the United States seeks an experienced Manufacturing Engineer to drive process optimization, equipment qualification, and change management in our medical device manufacturing facility.

You will bridge manufacturing engineering and quality compliance to ensure lines and automated equipment operate safely, efficiently, and in full FDA and ISO 13485 compliance. You will lead IQ/OQ/PQ validation lifecycles, manage DMCO using Agile PLM, perform FMEA risk analyses, and oversee

Qualifications

• Design, optimize, and debug manufacturing processes for medical devices.
• Lead validation lifecycle (IQ/OQ/PQ) across automated equipment.
• Implement risk-based approaches (FMEA) to improve quality and reliability.

Responsibilities

• Support day-to-day operations to improve yield and reduce downtime.
• Design, procure, and qualify tooling, fixtures, and production equipment for scale-up.
• Lead Manufacturing Transfer projects including line bring-ups and site transfers.

Skills

Process optimization

Equipment qualification

Change management

FDA/ISO compliance

FMEA

Validation lifecycle

Tools

Agile PLM

IQ/OQ/PQ protocols

Job description

We are seeking an experienced Manufacturing Engineer to drive process optimization, equipment qualification, and change management initiatives within our medical device manufacturing facility. In this role, you will bridge manufacturing engineering and quality compliance, ensuring production lines and automated equipment operate safely, efficiently, and in full compliance with FDA and ISO 13485 standards.

You will lead process validation lifecycles (IQ/OQ/PQ), manage engineering change orders (DMCO) using Agile PLM, execute risk management (FMEA) strategies, and oversee complex manufacturing line transfers and continuous improvement projects on the shop floor.

Key Responsibilities

Process & Manufacturing Engineering

• Support day-to-day manufacturing operations, driving yield improvements, cycle time reduction, and downtime troubleshooting.
• Design, specify, and procure tooling, fixtures, and production equipment to support manufacturing scale-up and optimization.
• Lead and support Manufacturing Transfer projects, including line bring-ups, site-to-site transfers, and process scale-ups.

Equipment & Process Validation (IQ/OQ/PQ)

• Author, execute, and analyze protocol reports for IQ, OQ, and PQ across automated manufacturing equipment, tooling, and test methods.
• Define operating windows, key parameters, and acceptance criteria based on statistical analysis and engineering principles.
• Ensure all validation documentation strictly aligns with FDA 21 CFR Part 820 and ISO 13485 guidelines.

Eligible employees may enroll in and receive benefits offered by Intellectt Inc., subject to applicable plan terms, eligibility criteria, and contribution requirements.

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.