Heidi Tu, Phd

Heidi Tu, Phd Email and Phone Number

Staff Mechanical Engineer at Beckman Coulter Life Sciences @ Beckman Coulter Life Sciences
Heidi Tu, Phd's Location
San Francisco Bay Area, United States, United States
Heidi Tu, Phd's Contact Details

Heidi Tu, Phd work email

Heidi Tu, Phd personal email

About Heidi Tu, Phd

Expertise: product design and development for medical and life sciences applications, design controls process, cross-functional project management, prototyping, component characterization, system integration, system characterization

Heidi Tu, Phd's Current Company Details
Beckman Coulter Life Sciences

Beckman Coulter Life Sciences

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Staff Mechanical Engineer at Beckman Coulter Life Sciences
Heidi Tu, Phd Work Experience Details
  • Beckman Coulter Life Sciences
    Staff Mechanical Engineer
    Beckman Coulter Life Sciences Mar 2018 - Present
    Indianapolis, Indiana, Us
  • Labcyte Inc. (Acquired By Beckman Coulter Life Sciences)
    Senior Consumables Engineer
    Labcyte Inc. (Acquired By Beckman Coulter Life Sciences) Mar 2018 - Jan 2019
    • Consumables Technical Lead responsible for managing existing and new products• Established a cross-functional consumables core team to drive more efficient product development aligned with industry best practices and company policy• Partnered with manufacturing team to create and streamline a quality control program for consumables products, including inspection of incoming lots• Served as a subject matter expert for resolving instrument integration concerns• Coordinated with vendors and marketing team to implement a standardized product labeling scheme and format• Guided and evaluated proposal requests from potential new suppliers for components and contract manufacturing services to mitigate single supplier risk• Initiated and managed a multi-cavity injection molding tool development project with a critical vendor to support significant anticipated growth• Communicated to upper management resource gaps and required skill sets for priority projects• Stabilized consumables portfolio (16+ active products) by translating tribal knowledge into formal design documentation and critically evaluating high-risk products • Resolved a manufacturing process failure at a third-party vendor and led initiative to improve the process with a lower cost, faster lead time, and more operator-friendly method• Drafted company’s first consumables design controls guidance document to streamline project deliverables for new product development• Established a formal template for organizing technical requirements to accelerate planning and verification phases of new products• Heavily revised product specification drawing (SolidWorks) to facilitate improved vendor communication and QC and to serve as a template for new products
  • Theranos
    Staff Engineer
    Theranos Oct 2014 - Oct 2017
    Palo Alto, Ca, Us
    • Technical team lead for group of 5 R&D engineers developing Class II medical devices and critical accessories• Working knowledge of FDA 21 CFR 820, FDA 21 CFR 809, ISO 13485, ISO 14971• Started and led cross-functional team discussions (R&D, quality, regulatory, manufacturing) to drive more effective product development strategies• Led product team's design control documentation and risk management (dFMEA, Hazard Analysis) efforts, which were translated to company-wide policies• Coordinated R&D and regulatory efforts for determining product labeling requirements• Supported complaint investigations for prior generation device and implemented design and process changes to address failure modes and improve device performance• Created timeline for a new product from concept to design transfer and delivered on schedule• Employed Design of Experiments (DOE) to conduct more efficient exploratory studies and identify critical design factors for new product design• Created Bill of Materials (BOM), manufacturing procedures, and Instructions for Use (IFU)• Designed, prototyped, tested components both in-house and through external vendors• Created assembly procedure and straightforward instructional video to expedite prototype transfer from R&D to manufacturing• Created a technical writing guide to greatly reduce R&D document rewrites and approval times• Performed mechanical characterization of thin-walled plastic parts (Instron)• Performed tolerance stackup analysis
  • Genentech
    Device Development Postdoctoral Intern
    Genentech Jul 2014 - Oct 2014
    South San Francisco, California, Us
    • Employed DOE for rapid characterization of both individual and multi-factor effects of an assembly process, performed statistical analysis of results, and wrote a technical report• Designed a test fixture and developed a test method for characterizing part dimensions on a CNC measuring system (Micro-Vu Vertex)• Designed a machined adapter and a 3D-printed test fixture to replicate the manufacturing site’s assembly setup• Developed test methods for an electromechanical testing system (Instron) and utilized high-speed video to capture failure events
  • Biomedical Microsystems Laboratory
    Nsf Grfp Fellow / Phd Student
    Biomedical Microsystems Laboratory Aug 2008 - Dec 2013
    • Developed a wireless implantable system for anti-cancer drug delivery in mice• Determined clinicians’ needs to drive design specifications• Conducted design, finite element analysis (FEA), and mechanical characterization of material and structural properties of polymer microbellows• Designed packaging to incorporate electrochemical actuator, catheter, wireless components, and commercial valve• Evaluated vendors for raw materials and components• Created detailed bill of materials (BOM) and assembly process flow chart• Generated and conducted protocols to assemble and characterize functionality of prototypes• Statistically analyzed test data to confirm device performance to specifications• Class 100 cleanroom experience• First author of 2 journal papers and 3 conference papers• Advisor: Dr. Ellis Meng
  • Therapeutic Bionanotechnology Laboratory
    Undergraduate Research Assistant
    Therapeutic Bionanotechnology Laboratory Aug 2007 - May 2008
    • Assisted in development of a chemotherapeutic drug delivery system for cancer treatment• Experience with good lab practices and managing complicated chemical reactions• Employed scanning electron microscopy for nanoparticle characterization• Co-authorship on 1 journal paper and 2 conference papers• Advisor: Dr. Lisa Brannon-Peppas
  • Kbrwyle
    Space Medicine Intern
    Kbrwyle Jun 2007 - Aug 2007
    Houston, Tx, Us
    • Attended astronaut space medicine training and revised astronaut certification tests• Created tools for budgeting astronaut schedule on the International Space Station (ISS)
  • Ethicon, Inc.
    Intern
    Ethicon, Inc. Jan 2006 - Mar 2006
    Raritan, Nj, Us
    • Statistically analyzed measurements of suture thread diameters to verify compliance• Translated laser cutter training and protocol documentation from English to German • Compiled conference presentation for production line managers and engineers
  • Booz Allen Hamilton
    Intern Research Assistant
    Booz Allen Hamilton May 2005 - Aug 2005
    Mclean, Va, Us
    • Researched radiation limits that affect International Space Station (ISS) altitude strategy• Performed loss of vehicle risk analysis for space shuttle based on orbit parameters• Developed quick reference guide for ISS vehicle specifications and crew requirements

Heidi Tu, Phd Skills

Biomedical Engineering Medical Devices Matlab Solidworks Biomaterials Data Analysis Labview Signal Processing Technical Writing Microfluidics Finite Element Analysis Microfabrication 3d Printing Drug Delivery Research Design Of Experiments Statistics Injection Molding Biomems Mems R&d Product Development Laser Cutting Photolithography Microsoft Word Microsoft Excel Powerpoint Microtechnology Optical Microscopy Cnc Mill Tissue Engineering Project Management Design Control Device Integration Manufacturing Parylene Deposition Spin Coating Soft Lithography E Beam Evaporation Profilometer Device Characterization Minitab Jmp Oracle Agile Plm Team Leadership Microsoft Office Microsoft Project Computer Aided Design Mechanical Engineering Geometric Dimensioning And Tolerancing

Heidi Tu, Phd Education Details

  • University Of Southern California
    University Of Southern California
    Biomedical Engineering
  • University Of Southern California
    University Of Southern California
    Biomedical Engineering
  • The University Of Texas At Austin
    The University Of Texas At Austin
    Biomedical Engineering
  • The University Of Texas At Austin
    The University Of Texas At Austin
    German
  • Humboldt-Universität Zu Berlin
    Humboldt-Universität Zu Berlin
    Germanistik

Frequently Asked Questions about Heidi Tu, Phd

What company does Heidi Tu, Phd work for?

Heidi Tu, Phd works for Beckman Coulter Life Sciences

What is Heidi Tu, Phd's role at the current company?

Heidi Tu, Phd's current role is Staff Mechanical Engineer at Beckman Coulter Life Sciences.

What is Heidi Tu, Phd's email address?

Heidi Tu, Phd's email address is he****@****ail.com

What schools did Heidi Tu, Phd attend?

Heidi Tu, Phd attended University Of Southern California, University Of Southern California, The University Of Texas At Austin, The University Of Texas At Austin, Humboldt-Universität Zu Berlin.

What skills is Heidi Tu, Phd known for?

Heidi Tu, Phd has skills like Biomedical Engineering, Medical Devices, Matlab, Solidworks, Biomaterials, Data Analysis, Labview, Signal Processing, Technical Writing, Microfluidics, Finite Element Analysis, Microfabrication.

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