Vacancy Life Sciences

SYSTEM ENGINEERING LEAD

We are looking for an (experienced) System Engineering Lead with a strong background in the development of complex medical or lab devices, following strict design control. You will work in a multidisciplinary team of engineers and scientists with experience in electronics, physics, optics, assay development and in vitro development – building a revolutionary medical testing device.

| JOB DESCRIPTION:

You will take the lead in collecting all the requirements from user interactions, market analyses and regulatory advice, and building a complete user requirements document. Together with the technical experts you will build a system architecture and translate this into the technical design specifications for the whole system. Throughout the development, you will organize design review moments and risk analysis sessions, follow up on technical progress, while updating and maintaining the requirements, using professional software tools. You will become the liaison between the different development teams, able to provide the eagle eye perspective in technical discussions. Your responsibilities

• Lead the collection and structuring of the user requirements, via professional software
• Interact with the different stakeholders: end-users, customers, regulatory bodies
• Interact with the technical experts to translate the user requirements into system requirements
• Become the representative of the system as a whole, the liaison between the specialists
• Track the requirements throughout the product development, via design reviews
• Track the risks and mitigations via different risk analysis methods
• Track the progress of the verification and validation activities

| WE ARE LOOKING FOR:

• You have a technical background in engineering, physics, biochemistry or similar
• You have experience in development of complex (medical) instruments
• Experience in IVD development is a strong plus
• Experience with requirement tracking software is a plus
• A team player with excellent communication skills and fluent in English

| WHAT YOU CAN EXPECT OF TMC:

TMC is a technology and science consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients in order to help them to be more competitive in an ever more global and faster changing technological world.

TMC is truly unique thanks to our business model called the Employeneurship model which comes as a true innovation for the High Technology consulting business. It's the business relationship of the 21th century for high skilled Engineers & Scientists, and our model is built around 5 main pillars:

• Permanent employment contract, offering you stability and security
• Individual profit sharing: know your market value and share in the profit your work generates
• One-on-one coaching and trainings designed to help you develop your entrepreneurial skills
• The competence cells structure, providing a strong relevant network
• The entrepreneurial lab: a playground for new ideas and a launching for start-ups

TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.