Manufacturing Engineer

Job Description Job Description Qualifications: Bachelor’s degree in engineering or related field Experience of at least 8 years in medical device manufacturing ISO 13485 and FDA environment Ability to perform root cause analysis and execute process validations (IQ, OQ, PQ) Understanding of statistical analysis (SPC, CPK, DOE) Skilled in equipment, tooling, and fixture design, testing, and implementation Knowledge of design tools, prototyping techniques, and process evaluation methods Strong analytical skills and decision-making ability Responsibilities: Design and validate manufacturing processes, equipment, and fixtures for catheter production Troubleshoot production issues and implement improvements for operational efficiency Lead projects to enhance production metrics such as uptime, cycle time, and throughput Collaborate with vendors to select and develop equipment suitable for manufacturing needs Support scale-up efforts from development to commercialization, including process validation and transfer