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ENGIBEX

Device development engineer

On site

Leuven, Belgium

Full Time

18-09-2025

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Skills

Communication Leadership Critical Thinking Risk Management Agile Methodology Decision-making Training Coaching Agile

Job Specifications

We are a Belgian engineering consulting firm that assists SMEs and large industrial organizations in bringing their innovation and R&D initiatives to life.

Job Description

As a senior engineer, you'll lead the design and development of medical devices, balancing technical depth with strategic impact. You'll work independently, guide cross-functional teams, and ensure alignment with business goals.

Key Responsibilities

Engage with surgeons to gather clinical input and translate user needs into technical requirements

Design new devices and improve existing ones, including technical drawings and specifications

Lead verification, validation, and documentation (DHF, Technical File)

Ensure compliance with QMS and support design transfer to manufacturing and regulatory teams

Drive process development: from manufacturing methods (e.g. milling, laser cutting) to quality inspection and post-processing

Collaborate with subcontractors and manage technical communication

Identify and implement process improvements and validations for new product introductions

Profile / Requirements

Product Design Expertise:

Strong skills in functional dimensioning, CAD, technical drawings, and numerical simulation tools

Experience with standard production processes (e.g., milling, forging, laser cutting)

Ideally familiar with medical bone screws, plates, and instruments

Professional Experience

Proven background in product design and development with a strong technical focus

Hands-on experience with Design History Files (DHF) and technical documentation

Regulatory & Quality Knowledge

Solid understanding of Medical Device Regulation (MDR) and ISO 13485

Experience with risk management tools (e.g., FMEA, Hazard Analysis)

Ability to ensure compliance independently throughout development activities

Communication & Collaboration

Fluent in English (spoken and written), especially for technical documentation and presentations

Comfortable communicating with internal teams, partners, surgeons, and subcontractors

Able to adapt communication style to technical and non-technical audiences

Leadership & Mentoring

Capable of leading technical discussions and mentoring junior team members or interns

Skilled in coordinating cross-functional teams to align on project goals and timelines

Work Ethic & Mindset

Rigorous, organized, and structured approach to work

Able to work independently with minimal supervision

Strong critical thinking and decision-making skills

Proactive in identifying and solving complex technical challenges

Additional Assets

Familiarity with Agile methodology is a plus

Experience setting up and validating new processes for product industrialization

Why join us ?

We offer you a position as a consultant within the fascinating world of high tech and innovation. We provide a complete package with on one side training, coaching and a close follow-up, and on the other side a balanced salary package with fringe benefits based on your capabilities and experience.

Working with us means choosing a long-term perspective, development possibilities, and a personal approach. A human-centered, diverse company that values and supports your physical and mental well-being.

About the Company

Belgian Hi-Tech and Engineering consulting company with a focus on R&D, product innovation and a heart for entrepreneurs. We work with SME's and larger industrial groups to help them realise their projects. With our offices in Brussels, we have a central location to provide qualified engineering solutions all over Belgium. Know more