Freelance Design Quality Engineer (ZZP)

In this role as Design Quality Engineer you have the opportunity to lead on setting Quality and Reliability targets for IGT Systems medical products so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved.

This involves being a confident advisor on quality and reliability engineering topics.

Your main responsibilities, among others, are:

• Ensure that appropriate Quality plans are made that include all stages of the products lifecycle and support Quality Plan design.

• Validates key design inputs like useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs.

• Provides effective oversight the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle.

• Leading quality related problem solving

• Using post-market data for analytics and statistics to report on the products performance in the market (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when required.

• Act as a single point of contact (person assigned to) for project team(s); youre responsible to ensure the products design quality related requirements/criteria are complete and meet the Quality standards for every project milestone.

• Make substantial contribution to integrate reliability engineering activities with the medical device development activities.

We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life, not just as a job. Were looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each year.

To succeed in this role, you should have the following skills and experience

• Bachelors engineering degree with 8+ years of experience / Masters degree with 5 years of experience; preferably in Quality- or Reliability Engineering role in the medical or aerospace industry.

• Ability to define detailed Quality and Reliability plans for new medical product developments to ensure those are Safe, Effective and Reliable.

• Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirements.

• Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality.

• Ability to partner with V&V teams to assure thorough Verification, Validation and Useability testing.

• Analyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.

• Ability to conduct reliability analysis to assess the risks associated with design concepts.

• Perform statistical data analysis, regression modeling, reliability growth assessment and reliability prediction.

• Experience with adequate and accurate review of DHF and DMR documents.

• Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971.

• Being certified DfSS greenbelt or blackbelt has a preference.

• Experience with working in multidisciplinary teams in a high-tech R&D environment.

• Effective interpersonal, written and oral communication skills expected.

• Ability and willingness to work at least 3 days in office.