Design Quality Manager - Medical Devices

Job Title

Job Description

The Design Quality (DQ) Manager is accountable for the system and hardware quality and risk management throughout the product life cycle. They provide 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 DQ Manager also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes
 

Your role:

• Driving compliance of Design control requirements and ensure product design quality met in new product development as well released product.
• Ensuring radiation safety regulations and requirements as per IEC standard / FDA guidelines are met in the product design
• Challenge the status quo on EMI/EMC impacts during product design change
• Collaborating with R&D Compliance team for CDR development in NPI
• Monitoring design control requirements are adhered in the NPI project as part of project core team
• Providing appropriate decision on project readiness to next phase / milestone considering quality aspects
• Providing          necessary process guidance and compliant solution to project team
• Challenge the status quo of Reliability targets in NPI project
• Deriving business solution by collaborating with cross functional team members
• Provide support on E2E process guidance for issues reported on released product
• Establish and support best practices for problem solving, root cause analysis, and solution selection tools
• Provide subject matter expertise during internal and external quality system audits

You're the right fit if you have:

• Minimum with an Engineering degree of any discipline with 12+ years of relevant industry experience
• Working experience in Systems and Software Engineering, Design Quality or Reliability Engineering
• Medical Devices experience is mandatory including pre and post market activities.
• Ability to define detailed design quality and reliability plans for new medical product developments including design transfer to ensure products 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, IEC 60601, IEC 62366, IEC 62304 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.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re 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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