Senior Mechanical Engineer, Medical Device Design & DFMEA

invoX Pharma; Diepenbeek; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

invoX Belgium N.V. seeks a Senior Mechanical Engineer to join the Device Development team. You will design, verify and industrialise invoX devices, applying ISO13485-aligned design controls and risk management.

You will lead CAD/PDM activities, perform analyses and liaise with manufacturers to meet quality and cost targets. You will coordinate with the Chief Engineer, apply robust design tools, and contribute to manufacturing readiness while working in a multi-cultural environment in Belgium.

Qualifications

• Master's degree in Mechanical Engineering or related field.
• Experience with medical device design and regulatory standards.
• Familiarity with design controls, QbD and risk management.

Responsabilités

• Support Chief Engineer in design and development of invoX devices.
• Establish and maintain design controls and version control.
• Lead CAD and data management activities with SOP alignment.
• Perform proof of concept through analytical and empirical testing.
• Assess design intent against required manufacturing capability and cost.

Connaissances

Master in Mechanical Engineering

Good understanding of medical device

Quality by design / design controls

Risk management / DFMEA

Autonomous, self-starter

Strong problem-solving abilities

Formation

Master in Mechanical Engineering

Outils

Creo (CAD/CAE)

JMP (statistics)

PDM software

Description du poste

invoX Belgium N.V. seeks a Senior Mechanical Engineer to join the Device Development team. You will design, verify and industrialise invoX devices, applying ISO13485-aligned design controls and risk management.

You will lead CAD/PDM activities, perform analyses and liaise with manufacturers to meet quality and cost targets. You will coordinate with the Chief Engineer, apply robust design tools, and contribute to manufacturing readiness while working in a multi-cultural environment in Belgium.