Rajeev Katti

Experience

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  Lumentum (Previously JDS Uniphase)

  Jan 1997 - Jan 2001

  Snr Reliability Engineer

  Joined start-up company Indx as a Development Engineer which was later acquired by JDS Uniphase (Company grew from 9 to 330 staff in 3 years, from sales of $100k to $200M per annum). Main achievements were:•Developed indirect long grating writing technique using short length phase masks as a team.•Developed grating writing set up for Gain Equalizers Optical Filters.•Continuous improvement of processes to achieve yield, cycle time and cost reduction.•Manage small projects related to product range extensions, cost reduction, reliability improvement and production problems.Sr. Reliability Engineer •Achieved MIL/ IEC/ Telcordia qualification for the first to fourth generation devices of Dual Fiber-Bragg grating, Gain Flattening Filter devices and Add/ Drop DWDM Modules.•Wrote qualification, reliability, FMA (Failure material analysis) and RMA (Return material analysis) reports as and when required.• Planned and carried out reliability related experiments on devices/ components and accelerated aging tests to estimate their lifetime using quantitative/qualitative analysis/weibel analysis.• Maintained a quality record of zero failures in the field for over 90,000 devices shipped. Show less

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  Renka Corporation

  Feb 2002 - Jun 2003

  Manager (Product and Business Development Photonic Components)

  Responsible for managing a staff of 30 with 7 engineers (development and sales), 20 technicians and accounts officer for development, manufacturing and marketing of fiber optic components. Initiated telecommunication services with existing resources in OFC splicing, testing and Network characterization.

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  Macquarie University

  Jun 2003 - May 2004

  Senior Scientific Officer (Contract)

  Under the guidance of Professor, conducted research in the area of characterisation of Two-Section Semiconductor Lasers involving mainly: - Design, develop, test and implement complex exponent, equipment, systems, and software.- Collect and analyse complex data through experiments and data analysis tools.- Develop and maintain rapport and communication with cross faculty research and engineering services. - Perform administrative functions associated with purchasing, research project planning, documentation and compliance. Show less

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  Ventracor Ltd

  May 2004 - Aug 2005

  Sr. R&D/ Systems Engineer

  Responsible for managing verification test activities of LVAS Class III Implantable Medical device. Compliance to relevant standards and provide technical support to manufacturing, QA and regulatory affairs. Main tasks though not limited to:- Testing and qualification of LVAS (Left Ventricular Assist System) Blood Pumps- Derive System Specifications from the inputs such as environmental, clinical, compliance, measurements and applicable standards requirements.- Planning and conducting Failure Analysis/ Accelerated Aging tests- Develop test techniques based on appropriate standards - Supervise and Conduct environmental testing as per GLP; Liaison with external test facilities- Produce Verification and Validation Test protocols and Reports as per EN45502/ ISO 13485, IDE and FDA QSR (21 CFR 820) guidelines- Investigate dimensional tolerance for manufacturing requirements for yield/ continuous improvement Show less

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  ResMed

  Aug 2005 - Nov 2015

  • Developed system validation strategies and plans, risk analysis and mitigations.• Developed project plans and monitor progress to ensure that milestones are met• Derived System Specifications from the inputs such as environmental, clinical, compliance, measurements and applicable standards requirements.• Identified, proposed and developed humidity test systems for compliance to ISO standards.• Identified, proposed and developed automated disinfection process to improve efficiency by 70%.• Planned and conducted Failure Analysis/ Reliability tests to achieve 95% reliability goals• Maintained compliance as per relevant ISO standards, TGA, FDA QSR (21 CFR 820) and GMP guidelines• Assisted with TGA, FDA, TUV audits as SME on relevant projects Show less Responsible for managing verification and validation activities for multiple projects and provide technical support to Design, QA and manufacturing engineering.• Lead a high performance team of Validation engineers and Technical Officers.• Aligned team planning and decision making with the senior management requirements.• Guided in defining Validation Strategies, development of design specifications, verification test plans, lab compliance and project schedules.• Ensured documentation for all phases of verification activities using EDM such as Objective.• Lead continuous improvement activities by improving the activities of V&V process.• Mitigated risk of non-compliance and related business risks throughout the development process• Assisted regulatory with test reports in support of regulatory submissions and with any queries, addressing any concerns with safety and efficacy.• Assisted with CAPA investigations• Identified and assist in developing software and tools for validation testing.• Recruited, defined job description, mentored, set KPI’s and managed performance of team members. • Set yearly budget and validation resource planning and Capex forecasting. Show less • Lead a team of Validation engineers and Technical Officers.• Produced Verification and Validation Plans, Test protocols and Reports as per ISO 13485 and FDA QSR (21 CFR 820) guidelines.• Planned and conducted Failure Analysis/ Accelerated Aging tests.• Conducted engineering investigations for verification of design changes to products and achieved performance or cost improvements for released products.• Assisted regulatory team with test data in support of 510K regulatory submissions and in response to concerns with safety and efficacy. Show less

  • Senior Validation Engineer (Complex Systems)

    Oct 2014 - Nov 2015

  • Validation Section Lead

    Oct 2007 - Sept 2014

  • Validation Engineering Team Leader

    Aug 2005 - Sept 2007
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  Medline Industries, Inc.

  Nov 2016 - Sept 2017

  QA Systems Officer

  - Maintain quality assurance policies and procedures to ensure compliance to ISO13485- Perform FMEA/ Risk Analysis for products and processes- Produced verification test protocols and reports as per ISO 13485 guidelines- As a team conduct product recalls, reworks and stock release- Organise internal and external tests as per relevant standards requirements- Resolve product complaints and non-conformances- Perform performance qualifications for QA functionality of ERP software system Show less

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  SONARTECH ATLAS

  Sept 2017 - now

  Validation Engineer

  • Validation of Sonar (acoustic) processors and associated systems in submarine space• Develop validation plans for multiple bid projects• Verify system safety requirements against relevant compliance standards.• Coordinate with X-team of system engineers, PMs and developers and conduct FATs• Integrated Logistics Support (ILS) for sonar sub-systems