Sr Manufacturing Engineer

Medtronic, Inc.

(North Haven, Connecticut)
Full Time Travel Required
Job Posting Details
About Medtronic, Inc.
Medtronic (www.medtronic.com), is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic's mission is: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.
Summary
This position is an individual contributor position with project leadership responsibility and will be located in North Haven, Connecticut; reports to the Contract Manufacturing Engineering Manager Boulder, Colorado.
Responsibilities
* Manage technical aspects of product and process transition to contract manufacturing partners. * localization activities and ECO process into Contract Manufacturing organization and Sustaining Engineering * Provide engineering technical support and guidance * Provides guidance in designs and works as a liaison to ensure `design for manufacturing??? elements are incorporated to improve yield and reduce costs. * Specify and procure capital equipment in support of manufacturing and test processes; evaluates new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment * Ability to meet at off hours to support CM locations across the globe with global time zone differences. * Conduct, coordinate and aid in formal Process Verification and validation testing including protocol development and execution. * Ensures adherence to product specifications, industry standards, and quality and regulatory procedures and requirements. * Ensures manufacturing and new processes adequately demonstrate specified process and test control capabilities * Champion for PFMEA, DFM, DFT, DFSS, CAPA and NCR requirements * Assist with selection and qualification of new materials and suppliers.
Ideal Candidate
* A minimum of 7-10 years of experience working in medical device manufacturing. * B.S. in Engineering, Manufacturing, or other technical field * Experience working with FDA and ISO Quality Systems and Regulations * Familiarity with SPC, Experimental Design, and Statistical Sampling Techniques. * Project management skills. * Experience with Labview a plus. * Experience with Agile PLM helpful. * Process verification and validation knowledge. * Lean manufacturing/Six Sigma understanding. * Effective communication skills with ability to influence cooperation and positive outcomes * International travel required. (Approximately 25%)

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