Senior Designer – Design Verification & Validation
Stark Pharma Solutions Inc · Irvine, CA · Yesterday
EngineeringFull-time
Hi, My name is Sravani Dasari from Vakula Tech Inc. We are hiring talented professionals for a Senior Designer Design Verification & Validation 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 Designer Design Verification & Validation Location: California Duration: Long Term Job Overview We are seeking an experienced Senior Designer Design Verification & Validation to support design verification, equipment qualification, documentation, and manufacturing process improvement activities in a medical device manufacturing environment. The ideal candidate will have experience with SolidWorks, Windchill, validation documentation, and cross-functional project support. Key Responsibilities Support equipment qualification activities including IQ, OQ, and TMV.Create, update, and execute validation and test protocols.Develop and revise engineering drawings using SolidWorks.Manage document creation, updates, and release through Windchill.Support equipment software validation and prepare validation requirements.Create and maintain PFMEA, process instructions, and technical documentation.Perform GD&T drawing reviews and support design verification activities.Develop DOE (Design of Experiments) for process characterization.Create and release project deliverables, design specifications, and material specifications.Support manufacturing activities, supplier transfers, equipment repairs, and continuous process improvements. Required Qualifications 5 8 years of experience in design verification, validation, or medical device product development.Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related discipline.Strong experience with SolidWorks and Windchill PLM.Hands-on experience with IQ/OQ/TMV, design verification, and validation documentation.Knowledge of GD&T, PFMEA, and DOE methodologies.Experience supporting manufacturing, engineering change documentation, and cross-functional projects.Strong technical documentation, problem-solving, and project management skills.Experience in a regulated medical device manufacturing environment is preferred. 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