Summary
Overview
Work History
Education
Skills
Accomplishments
Additional Information
Affiliations
Software
Timeline
Generic

Yehoshua Gefen

Senior R&D Project Manager
Binymina

Summary

A sophisticated solutions-focused Product Developer and R&D Program Leader with 14 years of product engineering and development success, driving significant improvements in process, quality, operations, user experience, and bottom-line revenue in the biotech and medical device space. Leading product innovation definition and strategy, workflow, and prioritization of product development investments, spearheaded cross-functional brainstorming initiatives generating inspiration for product innovation and pipeline. Exceptional ability to train and empower scientific and technical teams to deliver on new and improved designs, instilling accountability, rigor, and discipline throughout the product development lifecycle. A trusted advisor to senior leadership, guiding medical device and biotech design and development, controls, and modifications. Experienced in build dominant R&D teams to advance product development and quality, brand reputation, and market share. Repeatedly recognized for excellence, receiving multiple promotions. Focused and dependable program manager with proven track record in new employee training initiatives, document control and planning activities. Recognized for outstanding interpersonal, client and professional communication abilities. Highly efficient and accurate with strong planning, problem-solving and communication skills.

Overview

14
14
years of professional experience
4
4
Languages

Work History

R&D Project Manager

Eitan Medical
Netanya, Israel
01.2021 - Current
  • Managed large-scale development program, with production prospect of 10 million units per year and full-scale budget of over $8 million, for new combinational device (OBDS) with significant Pharma partner and collaborating with all program functions, including R&D, Quality, Manufacturing, Marketing, Clinical, Regulatory, Supply Chain, 3rd party contractors ,and suppliers.
  • Established and fostered communication channels and good working relationships with Pharma partners, stakeholders, program SME counterparts, and leads. Led activities and deliverables to customer satisfaction by understanding complex problems, collecting data, and identifying risks and program opportunities.
  • Provided company management with solutions, consultation, and strategies for customer proposals, questions, and open issues from feasibility stages and up to mature program milestones. Created reports and KPI analysis tools for measuring goals and objectives success criteria and for program overview of progression, risks and issues, and program-related projects such as semi-automation manufacturing line, ERP and BI integration, and agile product features and design inputs development activities.
  • Managed and concentrated all actions and communications on customer due-diligence and customer device maturity testing.
  • Controlled and coordinated clinical study project as part of product functionality and reliability testing.
  • Significant contributor in creating documentation for product development strategies, roadmap, program plan, risk assessment, and design control activities architecture
  • Intrinsic provider of tools, methods, procedures, and processes as part of PMO activity scope and program requirements. Created templates for reports and program dashboarding and was significant influencer on organization's portfolio management system SW identification activities.
  • Substantial contributor of training material, lectures, and primary "go-to" person for portfolio-program-project management knowledge
  • Participated in pilot tests and revised programs based on feedback and results.
  • Orchestrated smooth and efficient program development by collaborating cross-functionally across departments.
  • Worked with subject matter experts to develop and implement mentoring programs to promote better learner experiences.
  • Provided program management expertise in lean Six Sigma strategies and agile methods, practices and execution.
  • Devised creative solutions to critical customer and user needs.
  • Facilitated workshops and conducted one-on-one training to educate team members.
  • Managed multiple strategic projects with numerous sub-projects or workstreams.
  • Established milestones and objectives based on input from functional areas and stakeholders.
  • Coached team members on productivity strategies to accomplish challenging goals.
  • Built teams to address project goals and objectives for multiple projects.
  • Designed and developed programs and projects for dissemination to personnel.
  • Engaged and worked alongside cross-functional stakeholders to manage strategic initiatives.
  • Leveraged project management processes and tools to define and execute projects.
  • Researched industry best practices in support of training development and program content.
  • Managed and supervised administrative and daily program operations, complying with policies and regulations.
  • Identified program obstacles and communicated possible impacts to team.
  • Demonstrated strong writing and presentation skills to develop briefs, memorandums and analytical reports for clients.
  • Collaborated with business leadership to set priorities based on business needs, resource capacity and risk exposure.
  • Developed and maintained logistics workflows, procedures and reports.

R&D Project Manager

bb7
Madison
01.2019 - 01.2021
  • Responsible for all areas of program management, with focus on objectives and stakeholders management, activity scoping, URS to PRS translation, design control, feasibility stages, schedule and timeline management, performance metrics and KPIs, resource management, risk management, communications management, process development, and actively leading one or more PMO continuous improvement activities per initial goals while also helping on drafting and scoping RFQ's, SOW, and project proposals
  • Coordinating with, presenting to, and establishing reports with all levels of program stakeholders, including mid-level and executive functional and business unit leadership, global supply chain, shared services, and corporate counterparts
  • Creating processes, procedures, and work methods to apply as standard operation within PMO scope of activity - Medical bb7 product development, directing growth and strength of product development muscle within organization, leading teams on full lifecycle product development, complex projects, and product improvements. Actively conducting one or more PMO continuous improvement activities.
  • Overseeing $450K annual project budget, profit margins, development and management of 8-member R&D team
  • Building interdisciplinary cross-functional engineering and scientific teams while establishing influential team culture, identifying workflow performance improvement and training needs
  • Key role in revenue increase by maintaining 60% margin costs on all projects
  • Business Development Scrum Team Member participated in market research to support product pipeline strategy.
  • Pivotal team member on development of $300K project proposal for major medical device company, guiding scoping activities, presentations, goal setting, deliverables, creating requirement gap analysis process, table, and matrixes
  • Responsible for completion of $250K production line improvement project that included upgrading automated test systems, system verification, improvements to existing manufacturing environment, code review, and debugging; developed white paper for possible future activities and improvements

Technical Product Manager

BioProtect Ltd
Kfar Saba
01.2016 - 01.2019
  • Oversaw and coordinated people and financial resources to orchestrate entire product development lifecycle for biodegradable balloon medical technology and served as technical team leader on comprehensive support, training, and policy compliance. Was part of research team member charged with improving and identifying solutions to critical issues and
  • Guided 8-member multidisciplinary project team on successful completion of annual $400K project portfolio, which included research projects, test protocols, automation, and machinery installation strategies for R&D, Engineering, and Operations
  • Requirements in technological gap between working concept and producible product
  • Developed fully QMS-implemented training plan and training materials
  • Managed R&D supplier and subcontractor budget above $200K
  • Spearheaded implementation of ISO 7 Clean-room standards in GMP/ISO-compliant new production facility
  • Participated as R&D representative and product SME in over ten successful ISO audits (by DEKRA - notified body), both internal and external, leading to 75% increase in production yield
  • Created documentation for validation, verification, and test protocols; MOIs (Machine Operation Instruction), and SOPs (Standard Operating Procedures), including all IQ, OQ & PQ protocols
  • Took part in weekly quality meetings and was responsible for implementing various CAPA and ECOs, and supporting QA in building BOM-compatible CAD Drawing library.
  • Working on failure and root cause analysis and finding solutions to failure modes in product and assembly line
  • Took part in building pre-and post-market surveys from users and critical opinions
  • Took part in project team to manage pre-IDE documents with understanding of FDA 501K process and requirements
  • Oversight of ISO standards implementation and ensuring regulatory compliance with GMP/cGMP/ISO9001/ISO13485

R&D Lab Manager

BioProtect Ltd
Kfar Saba
06.2008 - 01.2016
  • Technical production laboratory leadership across various functions, including operations, production, manufacturing automation, process improvements, ERP implementation, and guiding team in projects to strengthen laboratory profitability, efficiencies, inventory, and processes
  • Increased production capacity from 30% to 90% through implementation of Lean principles
  • Improved sterilization and sanitization process, in-house and with subcontractors, participated in cross-functional team to overcome obstacles in product sterilization processes, and qualified through robust V&V protocols for terminal sterilization
  • Managed up to 10 lab workers and junior engineers in 2 teams, overseeing administration of monthly $28K employee and operations budget for ISO7 medical device cleanroom with three positive pressure HEPA units
  • Responsible for lab supplies and materials acquisition, staff training, onboarding, and integration of QA procedures into medical laboratory operations to meet company and product quality system goals. Implemented GMP standards and MDR regulation compatible work processes and procedures. Directed all aspects of lab and processes QC
  • Implemented strategies for successful automation and machinery installation projects (custom-made jigs and tools). Managed automation and process improvements resulting in 150% increase in production capacity
  • Managed $100K+ budget for R&D suppliers and subcontractors and functioned as Company Rep to suppliers and contractors, negotiating contracts, writing activity reports, managing cost estimates, and price quotations.

Education

Master of Science - Genetics

Tel Aviv University
Tel Aviv
04.2001 -

Bachelor of Science - Cellular Biology

Hebrew University of Jerusalem
Jerusalem
04.2001 -

Skills

ISO 13485 - Medical Device Dev

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Accomplishments

  • Joshua Gefen - page 4
  • Agile Project Management: Comparing Agile Tools - LinkedIn
  • Become an Agile Project Manager - LinkedIn
  • AXxTUR3UXIB0gOFg9Zx0DDIFX6Yi
  • Become an Agile Project Manager - LinkedIn
  • What is Data Science
  • Coursera Course Certificates 6TT86YYZ87C6
  • Data Science Orientation - Coursera
  • Tools for Data Science - Coursera 4ZAH9PPC5FJS
  • Open Source Tools for Data Science - Coursera Course Certificates
  • Cert Prep: Project Management Professional (PMP) - LinkedIn
  • Project Management Foundations - LinkedIn
  • ISO 14791 Risk Management for Medical Devices: Requirements Training - BSI
  • ENR-00911060
  • Skills
  • Medical Devices
  • Project Management
  • Product Development
  • R&D
  • Biotechnology
  • Start-ups
  • ISO Standards
  • Microbiology
  • Laboratory Skills
  • U.S
  • Food and Drug Administration (FDA)
  • Joshua Gefen - page 5

Additional Information

  • Agile at Work: , Building Your Agile Team - LinkedIn Agile at Work: Planning with Agile User Stories - LinkedIn Agile at Work: Driving Productive Agile Meetings - LinkedIn Agile at Work: Reporting with Agile Charts and Boards - LinkedIn Agile at Work: Getting Better with Agile Retrospectives - LinkedIn

Affiliations

  • PMI Affiliated - Project Management Institute
  • INCOSE Member - International Council on Systems Engineering

Software

Python

Java

Microsoft Project

Office 365

Power BI

OnePlan and SmartSheet

Sharepoint Power App and Automation

TFS - PRoject Requirements Traceability and Test Cases

Teams, Zoom, Google Meet and BlackBoard

ERP and CRM environments (SAP1, Salesforce, etc))

Arena - Engineering Change Management

Timeline

R&D Project Manager

Eitan Medical
01.2021 - Current

R&D Project Manager

bb7
01.2019 - 01.2021

Technical Product Manager

BioProtect Ltd
01.2016 - 01.2019

R&D Lab Manager

BioProtect Ltd
06.2008 - 01.2016

Master of Science - Genetics

Tel Aviv University
04.2001 -

Bachelor of Science - Cellular Biology

Hebrew University of Jerusalem
04.2001 -

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Yehoshua GefenSenior R&D Project Manager