When you join us you will work with a team of committed individuals who trust each other to deliver on the tasks at hand.
We support innovation and outofthebox thinking balanced with collaboration across functions and other teams.
Our leadership understands the need for continuous education and provides opportunities for further development.
Member of cross functional Electronics Gemba Team with responsibility for up to 8 medical device manufacturing assembly lines.
Execute Process and Equipment Validation/Verification Strategies for new or changing manufacturing process elements.
Execute Engineering Builds and assist with Material Qualification Planning to support new or changing component requirements.
Works with project teams and established work processes and proactively finds creative methods to reach desired performance levels.
Represent manufacturing on R&D project core teams responsible for deliverables collaborating with internal stakeholders and ensuring productivity.
Develop and maintain manufacturing process documentation including but not limited to: Manufacturing Process Specifications Device History Records Tooling/Equipment Specifications Preventative Maintenance.
Calibration procedures through Engineering Change Management (ECM) process.
Perform and document rootcause analysis for NonConforming Material Reports.
Summarize and report on departmental Safety Quality Delivery Productivity and Cost performance measures.
Use Lean/Six Sigma methodology to identify and drive Continuous Improvement Projects to enhance Safety Quality Delivery Productivity and Cost performance measures.
Perform and document Impact Assessments and Corrective Actions for Equipment Remediations associated with out of tolerance calibration results.
Proactively identify and address safety related issues through Near Miss Reporting Process.
Review product designs with R&D Sustaining and AME engineers for optimized manufacturability and ease of assembly from raw material to finish products.
Leverage Subject Matter Experts during problem solving exercise. Provide multiple whatif scenarios to find the best total cost solution with financial impacts and emphasis on delivery timelines.
Uses existing tools and best practices to report and track product and process metrics.
Informs others proactively about developments or issues that affect their work and their ability to meet commitments.
Reqirements:
Experience in the Medical Device or a similar regulated industry.
Knowledge or experience in SAP CAD modeling schematic drafting and electrical design knowledge is a plus.
Knowledge or experience in computer based automated testing.
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