Experience

Truepill

• United States
• Software Development
• 200 - 300 Employee

• Director, Manufacturing

  • Jan 2022 - Oct 2022

  Built Manufacturing, Quality and Fulfillment operations for Diagnostics medical devices from the ground up; Hired, coached and managed 18 team members Launched and managed manufacturing & fulfillment of Diagnostics medical devices for 4 major clients; Managed and streamlined Covid Wellness Program fulfillment operations servicing up to 40 clients; Spearheaded the operational launch of QuestDirect Fulfillment Program Managed NPI program operations activities including… Show more Built Manufacturing, Quality and Fulfillment operations for Diagnostics medical devices from the ground up; Hired, coached and managed 18 team members Launched and managed manufacturing & fulfillment of Diagnostics medical devices for 4 major clients; Managed and streamlined Covid Wellness Program fulfillment operations servicing up to 40 clients; Spearheaded the operational launch of QuestDirect Fulfillment Program Managed NPI program operations activities including Sourcing, Inventory management, Labeling, Packaging, 3PL partners, Shipping, Freight & Distribution

• Sr. Manager, Manufacturing

  • Aug 2021 - Jan 2022



Terumo Medical Corporation

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Program Manager

  • 2020 - 2021

  Program Manager for the development of a venous thrombectomy system (a Nitinol based catheter and a hand-held electromechanical device). Managed program timeline, budget and resources as well as contract manufacturers and contract developers Program Manager for the development of an Atherectomy system device. Managed program timeline towards First-In-Human and Design Verification & Validation Program Manager for the development of a venous thrombectomy system (a Nitinol based catheter and a hand-held electromechanical device). Managed program timeline, budget and resources as well as contract manufacturers and contract developers Program Manager for the development of an Atherectomy system device. Managed program timeline towards First-In-Human and Design Verification & Validation



Juul Labs

• United States
• Manufacturing
• 700 & Above Employee

• Senior Technical Program Manager

  • 2018 - 2020

  Program Manager for new products introduction, new automation programs and country launches for high volume device manufacturing. Managed Contract Manufacturers, component manufacturing and upstream suppliers in China Program Manager for new products introduction, new automation programs and country launches for high volume device manufacturing. Managed Contract Manufacturers, component manufacturing and upstream suppliers in China



Cerus

• United States
• Biotechnology Research
• 200 - 300 Employee

• Device Development Manager

  • 2015 - 2018

  Key contributor to the successful product development, manufacturing process development, process validation and regulatory CE Mark submission & approval of INTERCEPT Processing Sets for Platelets and Plasma with Alternate Plastics. Led the development of INTERCEPT Red Blood Cell (RBC) Processing sets (filled with diluent and additive solutions) and Filter sets disposable kits to support Phase 3 clinical trials in Europe. Partnered with Biomedical Advanced Research and Development… Show more Key contributor to the successful product development, manufacturing process development, process validation and regulatory CE Mark submission & approval of INTERCEPT Processing Sets for Platelets and Plasma with Alternate Plastics. Led the development of INTERCEPT Red Blood Cell (RBC) Processing sets (filled with diluent and additive solutions) and Filter sets disposable kits to support Phase 3 clinical trials in Europe. Partnered with Biomedical Advanced Research and Development Authority (BARDA) to develop the INTERCEPT RBC Processing sets and Filter sets disposable kits to support Phase 3 clinical trials in Puerto Rico and Continental US, as part of national countermeasure activities against emerging Zika virus. Show less Key contributor to the successful product development, manufacturing process development, process validation and regulatory CE Mark submission & approval of INTERCEPT Processing Sets for Platelets and Plasma with Alternate Plastics. Led the development of INTERCEPT Red Blood Cell (RBC) Processing sets (filled with diluent and additive solutions) and Filter sets disposable kits to support Phase 3 clinical trials in Europe. Partnered with Biomedical Advanced Research and Development… Show more Key contributor to the successful product development, manufacturing process development, process validation and regulatory CE Mark submission & approval of INTERCEPT Processing Sets for Platelets and Plasma with Alternate Plastics. Led the development of INTERCEPT Red Blood Cell (RBC) Processing sets (filled with diluent and additive solutions) and Filter sets disposable kits to support Phase 3 clinical trials in Europe. Partnered with Biomedical Advanced Research and Development Authority (BARDA) to develop the INTERCEPT RBC Processing sets and Filter sets disposable kits to support Phase 3 clinical trials in Puerto Rico and Continental US, as part of national countermeasure activities against emerging Zika virus. Show less



Haemonetics

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Process Engineer, Advanced Engineering

  • 2013 - 2015

  Technical Lead and Program Manager for various new product tender initiatives, quality improvement projects, cost reduction initiative programs. Managed the aging study and biocompatibility testing to support shelf life claims for worldwide disposable transfusion sets. Technical Lead and Program Manager for various new product tender initiatives, quality improvement projects, cost reduction initiative programs. Managed the aging study and biocompatibility testing to support shelf life claims for worldwide disposable transfusion sets.



Bio-Rad Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Packaging Engineer (Cold Chain Validation)

  • 2012 - 2013

  Primary contributor to the development and validation of primary, secondary and tertiary temperature-controlled packaging and shipping systems for new EQAS products launches in 2012. Managed special shipments to Japan, the largest single account customer, by providing temperature mapping and monitoring of products per pallet and M-1 cargo containers, to ensure products maintain -40C temperature requirement door-to-door. Created transport simulation models and generated shipping… Show more Primary contributor to the development and validation of primary, secondary and tertiary temperature-controlled packaging and shipping systems for new EQAS products launches in 2012. Managed special shipments to Japan, the largest single account customer, by providing temperature mapping and monitoring of products per pallet and M-1 cargo containers, to ensure products maintain -40C temperature requirement door-to-door. Created transport simulation models and generated shipping study data to develop transport temperature profiles to be used in future product stability assessment. Supported product compliance to EP25-A, a Clinical & Laboratory Standards Institute (CLSI) guideline. Show less Primary contributor to the development and validation of primary, secondary and tertiary temperature-controlled packaging and shipping systems for new EQAS products launches in 2012. Managed special shipments to Japan, the largest single account customer, by providing temperature mapping and monitoring of products per pallet and M-1 cargo containers, to ensure products maintain -40C temperature requirement door-to-door. Created transport simulation models and generated shipping… Show more Primary contributor to the development and validation of primary, secondary and tertiary temperature-controlled packaging and shipping systems for new EQAS products launches in 2012. Managed special shipments to Japan, the largest single account customer, by providing temperature mapping and monitoring of products per pallet and M-1 cargo containers, to ensure products maintain -40C temperature requirement door-to-door. Created transport simulation models and generated shipping study data to develop transport temperature profiles to be used in future product stability assessment. Supported product compliance to EP25-A, a Clinical & Laboratory Standards Institute (CLSI) guideline. Show less



Younger Optics

• Medical Equipment Manufacturing
• 200 - 300 Employee

• R&D Manufacturing Engineer

  • 2008 - 2011

  Key contributor in the development and initial launch of the Trilogy NuPolar lenses. Primary Engineer responsible for the characterization of the impact resistance performance of various types of in-house lenses vs. competitor products; and the effects of hardcoating technology, AR coating, mirror coating on impact resistance performance. Implemented short term and long term solutions to improve the impact resistance of Trilogy lenses. Key contributor in the development and initial launch of the Trilogy NuPolar lenses. Primary Engineer responsible for the characterization of the impact resistance performance of various types of in-house lenses vs. competitor products; and the effects of hardcoating technology, AR coating, mirror coating on impact resistance performance. Implemented short term and long term solutions to improve the impact resistance of Trilogy lenses.



Advanced Infusion

• San Dimas, CA

• Process Engineer

  • 2005 - 2008

  Process Engineer in a start up organization that designs, develops and manufacture infusion pumps and catheter systems for pain therapy. Process Engineer in a start up organization that designs, develops and manufacture infusion pumps and catheter systems for pain therapy.



Pall Corporation

• United States
• Manufacturing
• 700 & Above Employee

• Product Development Engineer

  • 2000 - 2005

  Product development engineer responsible for introducing several product enhancement initiatives to blood collection, separation, filtration and transfusion disposable sets. Led product enhancement projects, which include the following extension products: (i) addition of blood sampling diversion pouch, (ii) vented whole blood systems, (iii) enhanced Red Cell dual disk filtration system, and (iv) in-line protective sampling needle cover and donor needle guard. Key contributor to… Show more Product development engineer responsible for introducing several product enhancement initiatives to blood collection, separation, filtration and transfusion disposable sets. Led product enhancement projects, which include the following extension products: (i) addition of blood sampling diversion pouch, (ii) vented whole blood systems, (iii) enhanced Red Cell dual disk filtration system, and (iv) in-line protective sampling needle cover and donor needle guard. Key contributor to the initial launch of the first generation bacterial detection system to detect bacterial growth in platelets. Show less Product development engineer responsible for introducing several product enhancement initiatives to blood collection, separation, filtration and transfusion disposable sets. Led product enhancement projects, which include the following extension products: (i) addition of blood sampling diversion pouch, (ii) vented whole blood systems, (iii) enhanced Red Cell dual disk filtration system, and (iv) in-line protective sampling needle cover and donor needle guard. Key contributor to… Show more Product development engineer responsible for introducing several product enhancement initiatives to blood collection, separation, filtration and transfusion disposable sets. Led product enhancement projects, which include the following extension products: (i) addition of blood sampling diversion pouch, (ii) vented whole blood systems, (iii) enhanced Red Cell dual disk filtration system, and (iv) in-line protective sampling needle cover and donor needle guard. Key contributor to the initial launch of the first generation bacterial detection system to detect bacterial growth in platelets. Show less