Aruna Ranaweera

Experience

• 

  Princeton University

  Jan 1995 - Jun 1998

  Supervisor/Worker

  Supervised undergraduates employed at the Student Center (and vice versa)

• 

  UC Santa Barbara

  Jul 1997 - Aug 1997

  Researcher (Experimentalist)

  Mechanically tested and characterized high performance ceramic composites for the Structural Materials group at the Department of Materials.

• 

  UC Santa Barbara

  Jul 1999 - Dec 2004

  Research Assistant/Experimentalist at the Department of Mechanical and Environmental Engineering• Designed and constructed a $120,000 Optical Tweezer system that uses a focused laser beam to capture and manipulate microscopic particles such as biological cells, DNA, and polystyrene beads. Interfaced mechanical components, electronics, optics, data acquisition hardware and software, and imaging system• Modeled and quantified the nonlinear trapping capability of optical traps using stochastic control theory. Developed and implemented on-line calibration methods that are more efficient than existing off-line methods. Analyzed the performance of existing linear control algorithms and developed new nonlinear control algorithms Show less Teaching Assistant at the Department of Mechanical and Environmental Engineering• Taught, advised, and graded undergraduates in 9 different courses including: Engineering Dynamics, Design of Engineering Systems, Manufacturing & Materials, Mechanics of Vibrations, Digital Control, and Math of Engineering• Organized and evaluated ASME student design competitions• Lectured and supervised up to 100 students at a time• Mentored undergraduates interested in research and designLaboratory Designer at the Department of Mechanical and Environmental Engineering• Developed and organized 3 new undergraduate laboratory courses: Sensors, Actuators & Computer Interfacing (Mechatronics); Advanced Dynamics & Control Laboratory; and Basic Electrical & Electronic Circuits• Collaborated with academic faculty and technical staff to design syllabuses and experiments that can be taught in an effective and robust manner• Trained teaching assistants and staff in the use of mechatronic devices, computer software, and laboratory equipment Show less

  • Graduate Researcher

    Jul 2000 - Dec 2004

  • Teaching Assistant

    Oct 1998 - Dec 2003

  • Graduate Researcher

    Jul 1999 - Jun 2000
• 

  Stryker

  Jan 2005 - Aug 2016

  Corporate (Global) Process Owner for Product Design Control and Risk Management for all Stryker products (reporting to Stryker Headquarters in Kalamazoo, MI) • Leader of the global Design Control Team and the global Risk Management Team consisting of 22 Division Process Owners (subject matter leaders) representing every Stryker design division• Developed and implemented Design Control Phase 2, the second stage of evolution of Stryker's company-wide medical device design control process emphasizing the project management aspects of New Product Development in compliance with ISO 13485, FDA QSR, and industry best practices• Developed and implemented Stryker's first company-wide OEM Product Development process• Conducted in person corporate product development trainings for over 400 subject matter experts representing all Stryker design divisions (North America, Europe, and Asia)• Developed technical content pertaining to Critical Quality Attributes for the new AdvaMed “Library of Successful Quality Practices” (published October 2014) Show less Corporate (Global) Process Owner for Risk Management for all Stryker products (reporting to Stryker Headquarters in Kalamazoo, MI) • Leader of the global Risk Management Team consisting of 8 Division Process Owners (subject matter leaders) representing every Stryker design division• Developed and implemented Stryker's first company-wide medical device Risk Management process in compliance with ISO 14971 and industry best-practices• Conducted in person corporate risk management trainings for over 400 subject matter experts representing all Stryker design divisions (North America and Europe) Show less New product design quality assurance at Stryker Endoscopy• Ensured product design quality and implemented process quality control (inspection) methods for the Stryker 1188 HD Camera system, which was launched successfully in 2006 with a first-year Warranty-Return Rate (WRR) that met the pre-launch project goal and was 72% better than the previous-generation product launch.• Ensured product design quality and implemented process quality control (inspection) methods for the SERFAS Energy RF Ablation System generator, which was launched successfully in 2005 with a WRR that was 66% better than the pre-launch project goal• Developed and implemented Stryker Endoscopy’s first ISO 14971-compliant medical device Risk Management process Show less

  • Associate Director, Design Engineering Processes

    Mar 2012 - Aug 2016

  • Corporate Process Manager, Product Risk Management

    Mar 2010 - Feb 2012

  • Associate Quality Assurance Manager

    Feb 2009 - Feb 2010

  • Associate Advanced Engineering Manager

    Mar 2008 - Jan 2009

  • Senior Advanced Engineer

    Feb 2007 - Feb 2008

  • Advanced Engineer

    Jan 2005 - Jan 2007
• 

  AganaMed

  Feb 2020 - now

  Founder

  AganaMed LLC is a medical device consulting company that provides training and product development services for Medical Device Development and due diligence. Primary areas of expertise are Design Controls, Risk Management, Quality Assurance, New Product Development, and Business Process Optimization.aganamed.com