Principal Engineer, Manufacturing

ICU Medical•San Clemente, CA

1d•Remote

About The Position

The Principal Engineer, Advanced Manufacturing will conduct investigations of considerable complexity pertaining to the development of new designs, methods, materials, or processes, and investigate possible applications of the results. This role provides expert technical guidance and support to R&D in the design and implementation of high-quality new products and processes, through DFM, DFA, analysis, DOEs, and other problem-solving tools. The engineer will ensure processes used in production are producible, high quality, common, and cost-effective, and assure the implementation of best practices established by industry and the Advanced Manufacturing Engineering team. This position applies advanced manufacturing engineering theories and concepts, optimizing solutions from a systems point of view by considering the effect of any change on other parts of the systems and supporting functions. The role requires understanding design requirements of the final product, coaching other engineering disciplines, and helping update design standards and best practices through the design cycle. The Principal Engineer is accountable for hitting cost and timing targets, implementing high-quality tools, equipment, and processes, and validating operations facilities. This role identifies, creates, and leads new and existing methods for verification and validation, assuring PM plans align with internal requirements and regulations. The engineer will implement initiatives and cost savings as defined by leadership and assist business unit leadership in implementing roadmaps for core processes and process controls. This role leads DFM/DFA, Process Development, and PM plans with R&D, Suppliers, and Operations, and works on special projects as they arise. Work from home is permitted 100% of the time from anywhere in the US. 20-25% International and domestic travel is required per year.

Requirements

Bachelor’s degree in Electronics Engineering or closely related field (or foreign equivalent) plus ten (10) years of experience in the job offered or closely related occupation.
Knowledge of Electrical, Pneumatics and Controls system integration
Understanding of PLC related programming features and capabilities
Mechanical Tools/Fixtures/Equipment design and development
Experience with a broad spectrum of manufacturing and machining processes
SolidWorks 3D CAD design software and 3D PLM data storage
Understanding of Lean Manufacturing concepts and tools
Experience using Problem Solving, Error Proofing techniques and Assembly Best Practices
Knowledge of Six Sigma Methodologies
At least 3 years of process development and validation experience in the medical industry.

Responsibilities

Conduct investigations of considerable complexity pertaining to the development of new designs, methods, materials or processes, and investigate possible applications of the results.
Provide expert technical guidance and support to R&D in the design and implementation of high quality new products and processes, through DFM, DFA, analysis, DOEs, and other problem solving tools.
Ensure processes being used in production are producible, high quality, common and cost effective.
Assure implementation of best practices established by industry and the Advanced Manufacturing Engineering team.
Apply advanced manufacturing engineering theories and concepts.
Optimizes solutions from a systems point of view by taking into account the effect of any change on other parts of the systems and supporting functions.
Understand Design requirements of the final product, coach other engineering disciplines and help update design standards and best practices through the design cycle.
Accountable to hit cost and timing targets.
Implement high quality Tools, Equipment, and Process, and validation our operations facilities.
Identifies, creates and leads new and existing methods for verification and validation.
Assures PM plans line up with our own internal requirements and regulations.
Implement initiatives and cost savings as defined by leadership.
Assist business unit leadership in implementation of road maps for core processes and process controls.
Lead DFM/DFA, Process Development, PM plans, with R&D, Suppliers and Operations.
Work on special projects as they arise.