Summary Primary focus of this position is to support optimizing implementing and validating components elements of a medical device The candidate will assist in conducting design and process qualification and validation assist write technical documents validation protocols and reports perform coordinate hands-on testing of a device assist in failure investigations and support other activities from R D Quality Operations and Regulatory Affairs Essential Key Job Responsibilities including supervisory and or fiscal 1 Design serve as subject matter expert of components of a medical device including design evaluation for proposed changes to materials processes suppliers tolerances clinical use scenarios and international standards 2 Process Validation assists in the development and review of process validation IQ OQ and PQ to qualify process and design changes using statistical methods and software as appropriate 3 Documentation write protocols technical documents and reports Prepare and edit raw material specifications and drawings Assist in preparing verification and validation protocols and reports Review and update documents such as Design Input Requirements Design History File and End Item Specification 4 Test Method Development develop engineering test methods and clinically relevant simulated use test methods in conjunction with R D technicians prepare and assist in the validation of test methods 5 Testing coordinate perform lab bench testing conduct engineering and competitor evaluations assist with failure investigations and verification and validation activities 6 Training train technicians on new design and process development as well as recent test methods Other Responsibilities may include however are not limited to Assist in the support of Manufacturing Quality Regulatory R D to ensure systems are compliant with all internal and external guidelines Assist in design and process root cause analysis and support non-conforming product and complaint investigations Required Qualifications B S degree in Mechanical Engineering Biomedical Engineering Chemical Engineering or other related engineering discipline Experience 3-5 years of industrial experience in R D quality or process development preferably in medical device or other regulated FDA QSR and ISO environment Demonstrated hands-on technical aptitude Experience in process validation IQ OQ and PQ writing protocols and reports to support verification and validation activities for product commercialization ability to assist in executing validation Experience in creating and or interpreting engineering drawings specifications Excellent oral and written communication skills Ability to work in cross functional teams Preferred Qualifications Ability to analyze data interpret results and write reports Proficient in statistic software is a plus Knowledge of cGMP and GLP is a plus Training in Six Sigma or Design for Six Sigma is a plus Education and or Experience B S degree in Mechanical Engineering Biomedical Engineering Chemical Engineering or other related engineering discipline Experience 3-5 years of industrial experience in R D quality or process development preferably in medical device or other regulated FDA QSR and ISO environment Required Skills Optional Skills Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift

📌 R&d Engineer Ii (Karnataka)
🏢 BD
📍 Karnataka