Iris Hernández, PE, MBA, MBB

Experience

• 

  Medtronic

  Jan 2000 - now

  - New Product Development / Product Transfers and Value Engineering Leader for Cardiac Rythm Heart Failure Management (CRHF) and Cardiac Ablation Solutions (CAS)- Villalba North Building Space Strategy Leader. Develop and implement strategies to Free up space to allow New Product Introduction / Transfers. More than 10k sq. ft. of space freed up in around 4 years.- New Clean Room Expansion project- Provide Project Management, Process Validation coaching and technical guidance to engineers- Process validation, Problem Solving (Kepner Tregoe), Continuous Improvement and Project Management Subject Matter Expert- Coach Lean Six Sigma GB & BB projects- Lean Six Sigma instructor - Medtronic MBB certification Mostrar menos - CRHF & AFS New Product Introduction / Product Development / Product Transfer and Value Engineering Manager - Sourcing Project Management Office. Operations Liaison for Sourcing PMO Projects (Savings over 1.5M per year)- Lead cost Improvement Projects (6.5% reduction YoY)- North Building Space Strategy Leader. Develop and implement strategies to Free up at least 2,000 sq. ft. per year to allow New Product Introduction / Transfers- AFS Transfer Site Leader- Cell Operating System (COS) transformations Engineering Leader - Provide Project Management, Process Validation coaching and technical guidance to project and process engineers- Process validation, Problem Solving (Kepner Tregoe), Continuous Improvement and Project Management Subject Matter Expert- Coach Lean Six Sigma GB & BB projects- Lean Six Sigma instructor - Medtronic MBB certification- Develop and maintain Villalba site Project Hopper. Lead project hopper prioritization exercise with the site staff. Mostrar menos - Project manager of new product transfer. - Member of the extended development team. - Schedule and resources management. - Develop MTM's training, characterization, OQ and PQ strategies. - Coaching development activities execution (characterization, CSV, IQ, OQ, PQ, TMQ).- Coordination of development activities with operations. - Key player on design changes implementation and process development. - Coaching implementation of poka yoke tooling designs.- Yield improvement of 94% from technology to development phase using lean six sigma methodology. Mostrar menos - Team leader of manufacturing engineering group. Directly supervise a group of manufacturing engineers and engineering technicians. - Development and maintenance of products FMEA.- Lead yield improvement six sigma project. A total saving of $2M was obtained with this project. Worked as a Medtronic Lean Sigma Instructor.- Responsible for the development, training, qualification and validation activities of new products.- Lead MTM's training strategies to increase manufacturing line capacity and flexibility. Mostrar menos - Product transfers - Transfer coordinator of seven (7) new products. Responsible for the organization of the transfer team with the quality system, material, manufacturing, finance and technical services departments and their follow up in the transfer activities. - Development and implementation of new work cell layout to support capacity increase. - Development and implementation of fixtures and tooling to help in the product manufacturability.- Provide support to the manufacturing area in the process maintenance, fixtures update / development, PRB/MRB disposition, ECO implementation, TPCT and DPM control and reduction. - Assure quality concepts, specification requirements and regulatory aspects are reflected in the manufacturing procedures. - New employees training - Develop and implement training strategies for new employees at the manufacturing work cell. Trained over 200 new employees in a period of 5 months. - Implement corrective and preventive actions to address certain quality issues that could affect the yield, or does not comply with the quality system requirements. Mostrar menos

  • Engineering Director

    Oct 2021 - now

  • Sr. Engineering Manager

    Jan 2018 - Oct 2021

  • Engineering Manager

    Jan 2015 - Jan 2018

  • Senior Principal Manufacturing Engineer - New Products Introduction (R&D)

    Jul 2013 - Jan 2014

  • Principal Manufacturing Engineer - New Products Introduction (R&D )

    Jul 2011 - Jun 2013

  • Sr. Manufacturing Engineer - New Products Introduction (R&D)

    May 2008 - Jun 2011

  • Sr. Manufacturing Engineer - Operations

    May 2004 - Jan 2008

  • Manufacturing Engineer - Operations

    Jan 2000 - Jan 2004