Manufacturing Engineer — Process Optimization & Validation

Intellectt Inc; Norfolk (NE); Sur place; USD 85 000 - 110 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Process optimization

Equipment qualification

Change management

FDA/ISO compliance

FMEA

Validation lifecycle

Outils

Agile PLM

IQ/OQ/PQ protocols

Description du poste

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