In partnership with other functions, defining and managing the holistic patient and user safety, quality and reliability strategy and approach, overseeing execution and quality of results, driving to sufficient confidence in the product/service prior to release to market​.

Driving, coaching and supporting the use of Design Excellence methodologies like Design for Six Sigma (DfSS), Design for Reliability (DfR); as well as data driven Problem Solving and Root Cause Analysis methodologies. ​This includes delivering DfSS Black Belt and Green Belt Training; coaching Black Belt/Green Belt candidates to certification; working with peer DfSS champions/teams to update and maintain training materials.

Effectively analyzing and utilizing post-market data on the product’s field performance to identify system performance trends and/or improvement opportunities to continuously enhance Patient Safety and product quality and reliability.

Validating key design inputs like e.g usability, reliability, performance, safety, quality and their related test strategies to ensure appropriate statistical confidence and reliability levels.​​

Leading quality related problem solving.

Shaping advanced prediction data models to forecast system reliability and availability as input to project decisions and business roadmapping processes

Acting as a go-to subject matter expert for project team(s), business functions and design quality engineers in our team(s) to provide guidance or training on DfSS techniques like e.g. Quality Function Deployment, Design of Experiments. CtS/CtQ flowdown, Statistical Process Control and Tolerance Analysis. Next to problem solving methodologies and root cause finding techniques like e.g. 8D, Fault Tree Analysis, Fishbone Diagrams etc.

Developing and maintaining the knowledge and expertise resulting in state-of-the-art approaches to structured, data-driven product development, manufacturing and maintenance strategies that increase confidence and reliability of the safety and quality characteristics of our products. You will help to deploy best practices throughout the business by providing training, coaching and support to relevant functions.

PhD or Masters (MSc) degree in Physics, electrical, Mechanical or Industrial Engineering with 7+ years of relevant experience; preferably in Quality- or Reliability Engineering role in the medical or aerospace industry.

R&D background and mindset with knowledge of product and software development processes.

You have at least a DfSS Black belt certification and are willing to further develop towards Master Black Belt certification;

Strong experience in applying, coaching and training of DfSS and problem solving/root cause finding methodologies like IDOV, DMAIC, Statistical Engineering (Shainin tools), DOE, PDCA, SPC, 8D etc

Experience in manufacturing quality control and improvement programs is highly preferred;

Expert knowledge of Minitab; other SW tools like e.g. ReliaSoft would be a plus.

Ability to define test plans for new medical products that include risk based statistical approaches to obtain objective evidence that demonstrate appropriate confidence and reliability of safety and quality related product characteristics.

Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC60601, IEC62366 and ISO14971 would be a plus.
 

Motivated, self-driven with a determination to succeed and the ability to adapt to change.

Analytical, you are open to new ideas and believe in continuous learning in order to develop new competencies.

You combine analytical and conceptual thinking, physical insight, flexibility and a hands-on mentality to deliver sustainable results and creative solutions;

A critical but constructive business partner

Customer focused, have excellent communication skills and you are a team player.

Excellent reporting and documentation skills;

Excellent consultancy skills and the ability to connect with business stakeholders;

Good project management skills (sense of urgency).