Senior Mechanical Engineer: Medical Devices Design Controls

InvoX Pharma Limited; Belgique; Hybride; EUR 70 000 - 110 000; Plein temps

Résumé du poste

invoX Belgium N.V. is seeking a Senior Mechanical Engineer to support the Chief Engineer in the design and development of invoX devices, ensuring compliance with ISO13485 and robust Design Control practices.

You will lead CAD/CAE activities, maintain version control, perform DFMEA, and partner with manufacturing to industrialise scalable solutions that meet quality, safety and cost targets.

Qualifications

• Master in Mechanical Engineering with medical device context required.
• Experience with DFMEA and PFMEA processes critial.
• Familiarity with Design Controls and ISO13485 standards required.

Responsabilités

• Provide expertise in medical device design for development and verification of invoX devices.
• Establish and maintain design controls per invoX SOPs and regulatory guidelines.
• Maintain version control for devices in development and post-design freeze.
• Lead CAD/CAe and data management activities aligned with SOPs and drawing standards.
• Perform proof-of-concept activities and empirical verification.
• Apply analytical methods to ensure design intent and manufacturing capability.
• Create/review design inputs and align outputs for manufacturing partners.

Connaissances

Master in Mechanical Engineering

Medical device standards

QbD design controls

DFMEA

DFMEA to PFMEA

CAD/CAe Creo

Materials expertise

Formation

Master in Mechanical Engineering

Outils

Creo

JMP

PDM software

Description du poste

invoX Belgium N.V. is seeking a Senior Mechanical Engineer to support the Chief Engineer in the design and development of invoX devices, ensuring compliance with ISO13485 and robust Design Control practices.

You will lead CAD/CAE activities, maintain version control, perform DFMEA, and partner with manufacturing to industrialise scalable solutions that meet quality, safety and cost targets.