Manufacturing Engineer

Job Description Job Description Qualifications: Bachelor's degree in engineering or related fieldExperience of at least 8 years in medical device manufacturingISO 13485 and FDA environmentAbility 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 implementationKnowledge of design tools, prototyping techniques, and process evaluation methodsStrong analytical skills and decision-making abilityResponsibilities: Design and validate manufacturing processes, equipment, and fixtures for catheter productionTroubleshoot production issues and implement improvements for operational efficiencyLead projects to enhance production metrics such as uptime, cycle time, and throughputCollaborate with vendors to select and develop equipment suitable for manufacturing needsSupport scale-up efforts from development to commercialization, including process validation and transfer