Senior Design Quality Engineer – Products & Systems

What are you going to do as Senior Design Quality Engineer?

In this role, you have the opportunity to

• Lead on setting Quality and Reliability targets for medical products so that these innovative products deliver high quality and outstanding reliability to the lives they will improve.
• 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.
• Closely work with the post market teams to bring back the learnings from the fielded products (Installed base) and work with the R&D team to implement the design changes to fix the issues to make the products better.

• In partnership with other functions, defining and managing the 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.
• Ensuring that appropriate Quality plans are made that include all stages of the product’s lifecycle and support Quality Plan design.
• Validating key design inputs like usability, reliability, performance, safety, quality and their related test strategies to ensure appropriate statistical confidence and reliability levels.
• Providing effective oversight on the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle of the product.
• Leading quality related problem solving.
• Ensuring that the post-market data on the product’s performance is effectively used to make required design/process improvements through close collaboration with the cross functional teams.
• Acting as a go-to subject matter expert for project team(s) and business functions to provide guidance on all Design Control processes in the product design and development. You are responsible to ensure the product’s design quality related requirements/criteria are complete and meet the Quality standards for every project milestone.
• Make substantial contribution to integrate requirements engineering/CTS/CTQ flow down activities with the medical device development activities.

• Bachelor’s engineering degree with 12+ years of work experience or Master’s degree with 8+ years of work experience; 3-5 years work experience in Quality Engineering, Safety Engineering, R&D Engineering or equivalent role in the medical or aerospace industry. Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• Additional R&D background and mindset with knowledge of product and software development processes would be desirable.
• Preferably, you have a DfSS Green Belt certification and are willing to further develop towards Black Belt certification.
• Experience in applying problem solving/root cause finding methodologies
• Understanding of global medical device regulations, requirements, and standards, such as 21
  
  CFR
  820, ISO
  13485, EU MDR, IEC
  60601, IEC
  62366 and ISO
  14971 would be a plus.
• Ability to define detailed Quality and Reliability plans for new medical product developments to ensure those are Safe, Effective and Reliable.
• Ability to lead Risk Management and FMEA activities for new products and assurance that control measures are translated into 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 Verification & Validation 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.
• Strong experience with Systems Engineering methodologies / tools.
• Experience with adequate and accurate review of DHF and DMR documents.
• Experience with working in multidisciplinary teams in a high-tech R&D environment.
• Effective interpersonal, written and…