LUCYMARIE MANTESE

** ****** ***, *** *****, CA **403

512-***-**** (cell) acxkg8@r.postjobfree.com

Summary

Individual and team contributor with a range of capabilities including materials development, failure analysis of manufactured devices, and process development. Extensive experience in R&D to new product introduction.

Professional Experience

Ivy Sports Medicine (acquired by Stryker) 2016- present

Sr. Process Engineer (Materials Development)

Ivy Sports Medicine has developed a collagen-based meniscus implant (CMI).

Responsible for developing process parameters (4 optimizable variables) for a software-controlled medical heat sealer that is the sterilization barrier for the device.

Provide QC support for collagen material chemical tests.

PowerVision, Belmont, CA 2009- 2015

Senior Materials Scientist

PowerVision is developing a polymer-based accommodating intraocular lens (AIOL) for cataract replacement.

Supported R&D to develop and bring PowerVision’s lens into the clinic.

Responsible for developing plasma enhanced chemical vapor deposition (PECVD) processes. The PECVD surface treatments created hydrophobic or hydrophilic polymer surfaces depending on the application requirements.

Worked with Quality to identify and perform nessesary testing to address CAPAs.

Optimized the PECVD processes to meet manufacturing specifications, determined process windows with DOE methods.

Conducted process FMEAs.

Responsible for addressing failure mode after the device was released into the clinic for patient implant.

Led team to identify the root-causes of several lens and injector failures including: opacification of the lens, leaks due to adhesive, and injector cartridge damage to lens.

Used characterization methods such as SEM/EDX and optical microscopy to analyze the failed components. Developed processes and inspection steps to mitigate failures.

Reported to the management team updates and plan of actions.

Developed a bench-top test setup (developed fixtures and a saline flow circuit, purchased equipment) to simulate a vitrectomy surgical procedure. The model eye was used to understand how the polymer lens material changes with temperature fluctuations. Analyzed the data to determine clinical implications. Summarized data and reported to the team.

Designed test fixtures (SolidWorks) and procedure for a 3-point bend test (using Instron testing) to monitor material performance over time.

Responsible for biocompatibility testing of the lens material. The testing fulfilled ISO 10993 and 11979 and FDA requirements (e.g. cytotoxicity, hydrolytic stability, sensitization).

Part of the new Product Development team to outline the requirements for PowerVision’s next-generation intraocular lens. Defined and characterized a new material system used in the lens.

Xoft, Inc, Sunnyvale, CA 2007- 2008

Senior Physicist

Xoft has developed a radiation source to treat localized cancer, an area identified as electronic brachytherapy.

Worked with a team of physicists and engineers to develop an applicator to treat endometrial cancer that is compatible with the Xoft radiation source.

Determined the ratios of varying radiation-absorbing materials to deliver prescribed doses and coordinated prototype testing for FDA submission.

Experience with treatment planning software (BrachyVision). Initially the R&D team was relying on medical physicists off-site to develop prescribed treatment plans. This did not allow immediate testing and analysis. I took advantage of an opportunity to learn the software from a medical-physicist colleague so that treatment plans could quickly be made and modified as data were taken.

Experience with film-based testing to determine radiation dose profile. Introductory-level experience in Monte-Carlo simulation (MCNP).

Interfaced with physicians for customer feedback on applicator final design.

Nitinol Devices and Components (Johnson & Johnson), Fremont, CA 2005- 2007

Principal Engineer

Nitinol Devices and Components has developed nitinol-based stents and components to treat a range of medical conditions.

Worked with an outside vendor to develop a physical vapor deposition (PVD) process to increase the stent’s visibility (or radiopacity) under fluoroscopy. The coating was compatible with the stent platform, including meeting biocompatibility, fatigue and strain-related requirements.

Technical lead that interfaced with customers within and outside of Nitinol Devices and Components for applications related to the stent coating technology.

Made voice-of-customer visit and reported feedback from surgeons’ responses. Involved in animal testing experiments.

Led investigation of MEMs-based technologies for 3-dimensional surfaces.

Evaluated prototypes using commercially available technologies.

Agilent Technologies, (Fiber Optics Division) San Jose, CA 2000- 2005

Senior R&D Engineer

Member of materials group developing vertical-cavity surface emitting lasers (VCSELs) for Agilent’s fiber optics division.

Supported new product development and implementation into manufacturing.

Qualified a thin film chemical vapor deposition (CVD) system that became responsible for all Agilent, San Jose 850nm laser manufacturing.

Led team to develop and implement a real-time optical diagnositic to monitor the thin film deposition of AlGaAs material

Addressed device failures and product yield improvement.

Analyzed semiconductor laser devices for electrical, reliability and life-time performance.

Technical lead to develop a solution to a significant failure mode related to the VCSEL device. The failure resulted in a noisy laser output, low device yields and affected manufacturing and shipment dates.

Developed a novel deposition process to mitigate failures.

Tested final devices to ensure they passed all device requirements including:electrical output, reliability and life-time specifications.

Optimized the process by conducting materials characterization including AFM/SEM analysis and by performing a DOE to determine the process window.

Additional Skills

Statistical analysis of data sets, conducting DOEs, JMP and MiniTab softwares.

Film Deposition and coatings: Physical, chemical vapor deposition (PVD, OMCVD/PECVD), molecular beam epitaxy (MBE).

Surface analytical characterization: AFM, SEM, SIMS, XPS, Evans Analytical Surface Analysis Techniques.

Optical spectroscopies, microscopy and material tests (eg. UV-Vis, ellipsometry, MicroVu, Zeiss AxioScope, Instron).

MatLab, Experience with CAD software (SolidWorks).

Patent applications and proposal submissions.

Education/ Training

Postdoctoral Fellow, Physics, University of Texas, Austin

Ph.D., Physics, North Carolina State University

M.S., Materials Science and Engineering, North Carolina State University

B.A., Physics, Washington University, St. Louis

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