Design Quality Engineer - Medical Devices

Design Quality Engineer - Medical Devices

The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.

The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role:

• Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
• Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs
• Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle
• Perform independent technical assessment on product quality performance and post-market product quality analysis.
• Can Lead quality related problem solving and root cause analysis during design and manufacturing
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required.
• Performs independent technical assessment on product quality performance and post-market product quality analysis
• Provide leadership and oversight to ensure Quality Management System Compliance
• Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems
• Ensure the compliance requirements are met during Design review, design verification & Design validation, Design transfer
• Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving)

You're the right fit if you have:

• An Engineering degree in any discipline with at least 8+ years of relevant industry experience.
• Core expertise in Design Quality, Systems Engineering, or Reliability Engineering
• Medical device industry experience is mandatory
• Ability to define detailed systems 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 Usability testing
• Ability to lead reliability analysis to assess the risks associated with design concepts
• 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, and ISO 14971
• Experience with working in multidisciplinary teams in a high-tech R&D environment
• You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else
• You are a self-starter who embraces the change

How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an office-based role.

About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.