The Senior Manufacturing Engineer is responsible to provide manufacturing engineering support. Responsibilities will include support to process development, process changes / improvements, sustaining engineering, continuous improvement, and operations project management.
Day in the life : Lead the operations project team through development of detailed roadmap for operational project execution.
Collaborate with internal manufacturing sites to design, characterize and qualify high capability processes producing consistent finished device medical products.
This may include supporting process risk assessments (pFMEA), establishing process flows, support developing control plans, conducting process validations (IQ, OQ, PQ), and setting product acceptance criteria.
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to maximize efficiency and productivity.Designs sequence of operations and specifies procedures for the fabrication of equipment (excluding molds design) and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions.Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and supports corrective actions of problems and deficiencies to ensure product quality.
Lead operation changes and partner with those responsible for managing change within departments that will be affected.Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Authors and maintains manufacturing process documentation.Writes technical reports in support of submissions, project justifications, defect analyses, etc.
Maintain a standard for technical rigor in engineering consistent with the company performance expectations, including but not limited to advanced statistics, design of experiments, hypothesis testing, variables-data distribution analysis, attribute-data success testing, sample size calculation, process capability analysis, statistical process control.
Ensures all engineering activity is in full compliance with applicable quality systemBiomedical CompanyGreat Growth OpportunityAdvanced Degree - M.
S. or Ph.D. in Engineering, or similar relevant discipline4+ years of experience with Bachelors DegreeExperience with process development, process characterization, process verification and validation, or component / material qualification, and acceptance testing.
Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
Working understanding of statistics, including sample size selection, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variation.
A self-motivated team player with excellent verbal and written communications skills. Must be able to convey business and technical concepts to diverse stake-holders and technical teams in a clear and concise manner.
Ability to set work direction, work independently, and communicate with a vast network. Biomedical CompanyGreat Growth Opportunity