Senior R&D Engineer
Infosoft Inc.
Our Client is a Global medical device Manufacturer. Our client is seeking a Senior R&D Engineer to contribute to product engineering and design maintenance activities within a regulated manufacturing environment. This position will focus on evaluating engineering changes , reviewing technical drawings , maintaining controlled documentation , and preparing engineering reports . The engineer will work closely with cross-functional teams to address product-related technical issues and support design verification activities as needed. Candidates with hands-on R&D or product engineering experience in medical devices or another regulated industry are encouraged to apply. Review engineering drawings , product specifications , and technical records for accuracy and completeness. Support product design modifications and coordinate the associated engineering change-control activities. Update design documentation and ensure revisions are properly recorded and maintained. Draft, organize, and review technical reports, engineering assessments, and supporting documentation. Assist with the evaluation of product performance issues and contribute to technical problem-solving. Participate in product complaint reviews and help investigate potential technical causes. Support verification and validation activities by following established protocols and documenting results, as required. Work with engineering and quality personnel to address documentation gaps and engineering concerns. Coordinate with manufacturing and other stakeholders to communicate design updates and resolve implementation questions. Review engineering records for alignment with applicable quality procedures and regulatory expectations. Help maintain consistency across design records, drawings, specifications, and related technical files. Contribute to engineering reviews and provide technical input to support product changes and ongoing product improvement. Requirements: Bachelor's degree in Engineering, preferably Mechanical Engineering or Biomedical Engineering . Minimum relevant experience of 5 years with a bachelor's degree, or 2 years with a master's degree or PhD. R&D experience Practical experience reviewing engineering drawings, specifications , and technical documentation . Understanding design change processes, engineering change control , and documentation management. Ability to prepare clear technical reports and maintain accurate engineering records. Experience in a regulated industry, such as medical devices, pharmaceuticals, aerospace, or similarly controlled manufacturing. Ability to work collaboratively with cross-functional engineering and quality teams. Preferred: Experience with SolidWorks or comparable CAD software. Preferred: Exposure to verification and validation protocols, product complaint investigations, and technical root-cause analysis. Preferred: Familiarity with quality systems and regulatory documentation. #J-18808-Ljbffr Infosoft Inc.
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