Device development engineer

Engibex

  • Leuven, Vlaams Brabant
  • Vast
  • Voltijds
  • 7 dagen geleden
About company :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 Required qualifications :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 instrumentsProfessional Experience:
Proven background in product design and development with a strong technical focus
Hands-on experience with Design History Files (DHF) and technical documentationRegulatory & 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 activitiesCommunication & 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 audiencesLeadership & 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 timelinesWork 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 challengesAdditional Assets:
Familiarity with Agile methodology is a plus
Experience setting up and validating new processes for product industrialization

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