Systems Architect Electrical Engineering

High Tech Industry, Medical Devices

Our client is currently finalizing the development of their first generation product, a high tech medical device.

In this role, you have an opportunity to work as a Systems Architect Electrical Engineer and be part of a small team of experienced professionals working on all the product development aspects from drafting the requirements till performing validation and realizing the product. Alongside, interact with external development partners, manufacturing partners and the suppliers as part of product development. In this role you are the key person overseeing the entire product end-to-end from cycle.

You are responsible for: 

• System & Sub Systems Specifications – Overall translation of User, Regulatory, Manufacturing & Service requirements, Lifecycle Management 
• Owner of System & Sub Systems Specifications – Overall translation of User, Regulatory, Manufacturing & Service requirements, Lifecycle Management 
• Design Requirements Management, Decomposition of derived requirements and traceability, guiding design and development during the engineering phase and system integration 
• Design feasibility of potential solutions, design options and decision 
• Design Risk Management – Owner of Risk Management File (Risk Evaluation and Assessment) 
• Defect Management/Root cause analysis, debugging and problem solving 
• Designing process compliance assurance, design quality assurance and design reviews 
• Ensuring compliance to all internal QSPs and industry regulations and contribute to the creation of the processes 
• Provide support for technical roadmap inputs and advance research activities.

We are looking for a candidate who already has a residence in the Netherlands and has worked as a Systems Engineer with the following experience and skills:

• Strong knowledge and experience with Medical Regulatory Requirements associated with design controls - MDD, ISO 13485 and ISO 14971
• Or experience in a similar role in the end to end product design (electrical devices), for example he Automotive branch and willingness to learn the required knowledge by intensive training at the start of your assignment
• Hands on experience on FMEA, Fault Tree analysis, Reliability block diagrams preparation and RCA techniques 
• Demonstrated capability to conduct and lead technical reviews of product design elements 
• Knowledge of tools and processes related to system configuration management from specifications development, traceability, version control, defect tracking and field feedback 
• Master’s degree (or same level with proven track record) in electrical engineering or electronics 
• 5+ years of professional experience required

You'll get a contract directly at our client, a fast growing organization, with a competitive salary and benefits. Our client is a great and interesting company to work for, where you can be part of a new technology and innovation that helps the society.