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 RD 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
Youre 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 VV 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 RD 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