Ofir Gariani
Project Manager at Nanopass Technologies Ltd.- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Tamir Shefer
I am pleased to provide a recommendation for Ofir, who serves as a Project Engineer in NanoPass R&D team. From the moment Ofir joined, he quickly became a productive team member. Ofir's took control over NanoPass devices compliance with risk management ISO 14971 standard including updating to 2019 revision analytical mindset allowed him to identify and address potential risks proactively during our projects, including developing the risk management plan, conducting FMEA, and preparing comprehensive risk management reports. Ofir served as our sterilization validation (ETO) PMO, was very passionate and dedicated with excellent personal relationships that helped us to complete the project successfully and ahead of time. It was a pleasure working with Ofir. He consistently demonstrated professionalism, dedication, and commitment to excellence. His ability to deliver high-quality work and meet deadlines made him a reliable asset to our team. I recommend Ofir for any role that requires a diligent and skilled professional.
Tamir Shefer
I am pleased to provide a recommendation for Ofir, who serves as a Project Engineer in NanoPass R&D team. From the moment Ofir joined, he quickly became a productive team member. Ofir's took control over NanoPass devices compliance with risk management ISO 14971 standard including updating to 2019 revision analytical mindset allowed him to identify and address potential risks proactively during our projects, including developing the risk management plan, conducting FMEA, and preparing comprehensive risk management reports. Ofir served as our sterilization validation (ETO) PMO, was very passionate and dedicated with excellent personal relationships that helped us to complete the project successfully and ahead of time. It was a pleasure working with Ofir. He consistently demonstrated professionalism, dedication, and commitment to excellence. His ability to deliver high-quality work and meet deadlines made him a reliable asset to our team. I recommend Ofir for any role that requires a diligent and skilled professional.
Tamir Shefer
I am pleased to provide a recommendation for Ofir, who serves as a Project Engineer in NanoPass R&D team. From the moment Ofir joined, he quickly became a productive team member. Ofir's took control over NanoPass devices compliance with risk management ISO 14971 standard including updating to 2019 revision analytical mindset allowed him to identify and address potential risks proactively during our projects, including developing the risk management plan, conducting FMEA, and preparing comprehensive risk management reports. Ofir served as our sterilization validation (ETO) PMO, was very passionate and dedicated with excellent personal relationships that helped us to complete the project successfully and ahead of time. It was a pleasure working with Ofir. He consistently demonstrated professionalism, dedication, and commitment to excellence. His ability to deliver high-quality work and meet deadlines made him a reliable asset to our team. I recommend Ofir for any role that requires a diligent and skilled professional.
Tamir Shefer
I am pleased to provide a recommendation for Ofir, who serves as a Project Engineer in NanoPass R&D team. From the moment Ofir joined, he quickly became a productive team member. Ofir's took control over NanoPass devices compliance with risk management ISO 14971 standard including updating to 2019 revision analytical mindset allowed him to identify and address potential risks proactively during our projects, including developing the risk management plan, conducting FMEA, and preparing comprehensive risk management reports. Ofir served as our sterilization validation (ETO) PMO, was very passionate and dedicated with excellent personal relationships that helped us to complete the project successfully and ahead of time. It was a pleasure working with Ofir. He consistently demonstrated professionalism, dedication, and commitment to excellence. His ability to deliver high-quality work and meet deadlines made him a reliable asset to our team. I recommend Ofir for any role that requires a diligent and skilled professional.
Credentials
-
Communication Foundations
LinkedInOct, 2023- Sep, 2024 -
Business Analyst and Project Manager Collaboration
LinkedInSep, 2023- Sep, 2024 -
Problem Solving Techniques
LinkedInAug, 2022- Sep, 2024 -
Project Management Foundations: Budgets
LinkedInJun, 2022- Sep, 2024 -
Medical Device Risk Management Workshop
Bioforum the Data MastersSep, 2020- Sep, 2024 -
Solid Edge Basic
McKit SystemsJun, 2018- Sep, 2024
Experience
-
Nanopass Technologies Ltd.
-
Israel
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
Project Manager
-
Jan 2022 - Present
- Directly manage a team to effectively deliver solutions for global clients. Responsible for ensuring what the project delivers is valuable and meets the needs of the business and customers.- Participant in the technical file writing of intradermal drug delivery medical device to be submitted to the MDR and the FDA.- Acting as a technical advisor for human factor and user experience, instruction for use, risk management and design V&V files for authorities’ submission.- Create and maintain DHF per product - Supported inspections and audits of big costumers, including exhibition of a new product development process- Write product requirement documents (PRD) such as product validation master plan and SPECs.- Transitioned NPI and new process product to the manufacturer site and gathered insights using OEE tools to acheive conclusions in order to improve yield.- Led successful CAPA and NC investigations utilizing root cause analysis techniques.- Leading meetings to improve collaboration and accelerate processes. Collaborated effectively with multi-disciplinary teams such as- medical, software development, plastics, QA, and regulatory departments to ensure seamless integration of project components and successful completion of cross-functional initiatives- Lead devices hand-off to customers together with the business department- Promote manufacturing, assembly, test processes for new products including SoW agreements with potential manufacturers.- Ability to multi-task and work under pressure.- Compose software validation standard operating procedure based on ISO-80002 and sample size determination for R&D tests based on statistical methods and ISO- 16269-1 and ISO-2589-1 Show less
-
-
Product development and Engineering Leader
-
Apr 2020 - Jan 2022
- Managed Engineering Change Orders (ECOs) processes- Defined the Product and the Project. Responsibility for end-to-end product development that begins from understanding customer needs and ends with delivery to the customer, including project’s roadmap, budget and timeline management.- Drawing, design, and printing prototypes and new apparatus for lab testing using SolidWorks and 3D printers.- Managing design review meetings and creating PRD, foreseeable misuse, usability, and instruction for use files - Experience in working under regulated environment working according to ISO- 13485- Risk management - leading the company’s risk management processes and applying the risk activities according to ISO-14971, TR-24971- Collaborated closely with software developers to create an image processing QC software upon request. The software's purpose was to verify the integrity of the product based on its shape and dimensions.- Traveled to project sites abroad to perform start-up and training services.- R&D Laboratory management includes maintaining, calibrating, inventory and Purchasing. Show less
-
-
-
INSIGHTEC
-
Israel
-
Medical Device
-
300 - 400 Employee
-
SW Testing Engineer
-
Jul 2019 - Apr 2020
- Performed MRI exams and ensured diagnostic images were recorded correctly - Created a new tool for Automatic testing using PowerShell and VBA. - Created test cases for new medical product development to identify problems and leads the effort to solve software issues.. - Created and updated testing documents (STDs). - Integrated and collaborated between SW team members and R&D departments - Prompted and hold Design Reviews meetings for teammates and Management personnel - Performed MRI exams and ensured diagnostic images were recorded correctly - Created a new tool for Automatic testing using PowerShell and VBA. - Created test cases for new medical product development to identify problems and leads the effort to solve software issues.. - Created and updated testing documents (STDs). - Integrated and collaborated between SW team members and R&D departments - Prompted and hold Design Reviews meetings for teammates and Management personnel
-
-
-
-
Testing Engineer
-
Apr 2018 - Jul 2019
- R&D Laboratory management including maintaining, calibrating, inventory and Purchasing. - Performing laboratory tests, technical tests, and pre-clinical tests. - Design of experiments and protocols. Writing VP, VR, ETR process documentation, and WI. - Designed and conducted statistical gage tests and analyzed statistical data. - Participate in departmental tasks that include problem-solving and root cause analysis. - Data analysis and generating reports. - Present final experiment results to C-level executives, including CEO and COO Process Engineering; - Sterilization Validation process management - Experience in working according to ISO 10993-7 requirements Show less
-
-
-
digitalrep
-
United States
-
Software Development
-
1 - 100 Employee
-
Medical tele-detailing (Medical Representative)
-
Oct 2017 - Apr 2018
- Keeping up-to-date with the latest products updates and clinical data. - Promoting medical products and services to potential customers. - Collecting and maintaining doctors and hospitals data. - Filling out side effects reports. - Keeping up-to-date with the latest products updates and clinical data. - Promoting medical products and services to potential customers. - Collecting and maintaining doctors and hospitals data. - Filling out side effects reports.
-
-
Education
-
2015 - 2019
Tel Aviv University
Bachelor's degree, Bio-Medical Engineering
Community
