Senior Manufacturing Engineer

Hi, My name is Sravani Dasari from Vakula Tech Inc. We are hiring talented professionals for a Senior Manufacturing Engineer position. If you have relevant experience and are interested in this opportunity, please send me your updated resume. The detailed job description is as follows. Position: Senior Manufacturing Engineer Location: Indiana Duration: Long Term Job Overview We are seeking an experienced Senior Manufacturing Engineer to support manufacturing process development, equipment validation, and continuous improvement activities in a regulated medical device or pharmaceutical manufacturing environment. The ideal candidate will have strong experience in validation, quality systems, process optimization, and manufacturing engineering. Key Responsibilities Lead equipment qualification activities, including IQ, OQ, and PQ.Develop and execute validation protocols and prepare validation reports.Support manufacturing process improvements and equipment optimization.Perform risk assessments, including FMEA, and support CAPA activities.Conduct process capability studies using statistical tools such as Minitab or JMP.Support metrology, calibration, Gauge R&R, and measurement system analysis.Ensure compliance with ISO 13485, GMP, and 21 CFR Part 820 requirements.Maintain validation and quality documentation using eQMS and document control systems.Collaborate with cross-functional teams to resolve manufacturing and quality issues.Support continuous improvement and validation projects. Required Qualifications 5 10 years of manufacturing engineering experience in a regulated medical device, pharmaceutical, or healthcare environment.Bachelor's degree in Mechanical, Manufacturing, Biomedical Engineering, or a related discipline.Hands-on experience with IQ/OQ/PQ validation activities.Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820.Experience with FMEA, CAPA, metrology, and calibration.Knowledge of CNC machining, CAM software, and basic CNC programming.Experience using Minitab, JMP, or similar statistical analysis tools.Familiarity with MasterControl, ETQ, or other eQMS/document control systems.Strong analytical, troubleshooting, and communication skills. I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you. Please follow Vakula Tech Inc. on LinkedIn for the latest job updates: https://www.linkedin.com/company/vakula-tech Thank you, Sravani Dasari Talent Acquisition Specialist Vakula Tech Inc. Email: jobs@vakulatech.com Piscataway, New Jersey 08854 Website: www.vakulatech.com