Manufacturing Engineer - CETOL

As a Senior Manufacturing Engineer, your role will involve reviewing and validating engineering drawings for manufacturability, accuracy, and completeness according to the latest engineering standards. You will apply your knowledge of medical device regulations to execute gap assessments, manufacturing print reviews, and remediation activities. Additionally, you will participate in ideation activities to assess project scoping and viability through economic analysis, conflict analysis, and supplier quote validation. Key Responsibilities: - Review and validate engineering drawings for manufacturability, accuracy, and completeness. - Apply knowledge of medical device regulations for gap assessments and remediation activities. - Participate in ideation activities for project scoping and viability. - Coordinate with suppliers to ensure timely and high-quality project delivery. - Conduct tol-stackup studies and dimensional variation analysis. - Plan, schedule, and monitor project activities efficiently. - Collaborate with global stakeholders across regions. - Review and validate PPAP reports from suppliers. - Utilize Engineering Change management procedures. - Perform DFMEA/PFMEA and design reviews. - Develop detailed 2D drawings and 3D CAD models. - Assist in developing Master Validation Plans. - Conduct CPK and ANOVA studies. - Perform criticality analysis for process reliability and quality. Qualifications Required: - Bachelor's degree in mechanical/production engineering. - Minimum of 9-12 years of relevant experience. - Strong expertise in DFM&A principles and manufacturing methods. - Proficiency in CAD (Creo/SW) and PLM/PDM tools. - Understanding of project management methodologies. - Excellent verbal and presentation skills. - Proficient in MS PowerPoint and Excel. - Experience with PPAP, Root Cause Analysis, and continuous improvement processes. Additional Details: - Experience in should costing with metals and plastic commodities. - Familiarity with electronic components and their design specifications. - Knowledge of Six Sigma methodologies and Lean Manufacturing principles. - Experience with VAVE projects, GD&T Certification, and PMP training/certification. This position offers the opportunity to leverage your expertise in manufacturing engineering, project management, and collaboration with global teams to drive efficiency and quality in medical device production processes.,