Design Quality Engineer - Medical Devices
Design Quality Engineer - Medical Devices
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Job Description
Job Title
Design Quality Engineer - Medical DevicesJob Description
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)
Youre 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 companys facilities.
Field roles are most effectively done outside of the companys 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 wont 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.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If youre interested in this role and have many but not all of the experiences needed we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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Employment Type
Full-Time
