Caleb Osborne Email and Phone Number
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Program and strategic product manager with proven design and management experience in medtech and other regulated industries. Core team leader with global experience in several 510(k) and CE mark submissions in surgical robotics and digital healthcare.Experienced technologist with the ability to lead HW, SW and Mechanical engineering development efforts.My goal through my work is to make a better world through the products I create. This leads me towards any industry and product that has the ability to help people live healthier lives in a cleaner, greener world. Currently interested in medical devices, alternative energy, autonomous vehicles, healthcare data management, and similar.Core Skills:- Cross-functional core team leadership in strong-matrix organizations to drive product business case, definition, development, qualification and launch.- Program management of capital, reusable and disposable medical devices through concept, regulatory submission and approval, and product launch.- Leading product development concepts and processes: requirements development, FMEAs, verification plans, tollgate/milestone tracking, kaizen events, lean manufacturing and formal problem solving.- Definition, design, and project management in the medical device and other regulated industries.- Creating feature funnels and roadmaps via business planning, resource management, NPV/IRR analyses.- Consolidating voice of customer data into prioritized, actionable new product development opportunities.- Developing and executing preclinical design validation for large scale medical devices.- Designing for machining, die-casting, plastic injection molding, cast urethanes, additive manufacturing.
Asensus Surgical
View- Website:
- asensus.com
- Employees:
- 278
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Director, Product DevelopmentAsensus SurgicalRaleigh, Nc, Us
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Director Of Product DevelopmentAsensus Surgical Mar 2022 - PresentDurham, North Carolina, Us
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Senior R&D Manager, Product DevelopmentAsensus Surgical Mar 2021 - Mar 2022Durham, North Carolina, Us- Responsible for next generation product development of AI/ML and robotic technology to deliver on the company's vision for Performance Guided Surgery.- Define product strategy and system architecture through user needs analysis and- Represent business imperatives and communicate strategy to internal teams to drive engagement and employee satisfaction.- Conduct business development with strategic partners to accelerate product development timeline.- Staff and manage multiple product development teams to deliver on product requirements with aggressive timeline goals.- Coordinate multiple SW, HW, Industrial Design, Graphic Design, Manufacturing and Regulatory vendors and consultants to enhance skills of internal team.
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Program ManagerAsensus Surgical May 2017 - Mar 2021Durham, North Carolina, Us- Lead cross-functional core teams for full product development of surgical robotic instrumentation including capital, reusable and disposable equipment for FDA 510(k) submission and CE Notified Body review.- Serve as strategic leader and decision-maker for core team while escalating tactical team issues with senior leadership.- Report program status to executive council on monthly basis.- Manage resource, scope, budget and schedule for concurrent >$2M projects.- Define and manage external relationships with business development partners through concept, development agreement, and supplier agreement.
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Senior EngineerAsensus Surgical Jan 2017 - May 2017Durham, North Carolina, Us- Developed preclinical design validation study for surgical robotics 510(k) submission for 100% traceability to user needs.- Executed logistics for four design validation procedures with ten pilot runs and six surgeons to deliver successful study results on time and under budget. - Resolved minimal FDA 510(k) Additional Information questions without requiring further testing.
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Project Engineer IiiAsensus Surgical Jan 2016 - Jan 2017Durham, North Carolina, Us- Wrote proposals, business plans, project plans for new development from research to systems/solutions engineering.- Performed feasibility studies, technology analysis and roadmap development 1:1 with CTO.- Consolidated voice of customer data into user stories and customer requirements.- Managed resource, scope, budget and schedule for >$1M project.- Lead teams with external resources, partners, and global workforce.- Utilized Kanban, Gantt, Jira, Confluence, JAMA, PDWare, Smartsheet/Project, and other project management tools to coordinate team success.
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Mechanical Design Engineer IiAsensus Surgical May 2014 - Jan 2016Durham, North Carolina, Us- Managed prototype build, V&V testing and 510(k) activities for large electromechanical subassembly responsible for precise, reliable input and output of surgical robotic equipment.- Served as mechanical subject matter expert for motor control system to improve accuracy and reliability of robotic system.- Designed mechanical components and assemblies from pre-revenue initial design to product release of surgical robotic equipment. - Integrated design changes focused on usability and cleanability of capital equipment.
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Mechanical Engineer / Hydraulics TeamGilbarco Veeder Root Jul 2012 - May 2014Greensboro, N.C., Us- Exercise advanced data analysis techniques for product lifecycle support, especially with respect to field data acquisition and analysis but also with internal (on- and off-line) data acquisition and live tracking.- Designed hydraulic components for retail fuel dispensers with a focus on regulatory and material compatibility. Specialized in mechanical valve and seal design.- Design experience in die cast and machined components as well as plastic injection molded applications.- Managed US regulatory certifications of new products and supplier components.- Create and maintain product and test specifications. Develop standard test output for components to contribute to uniform "book of knowledge."- Utilized concepts and processes of product development: MRS/PRS/TRS, FMEAs, tollgate/milestone product development tracking, kaizen events, formal problem solving.- Maintained engineering supplier relationships for purchased assemblies. -
Engineering InternGilbarco Veeder Root May 2011 - Aug 2011Greensboro, N.C., Us1. Researched and designed prototypes of proprietary fuel management systems.2. Implemented mechanical sensing equipment into fuel management systems.3. Analyzed fluid mechanical interactions with fuel management equipment.4. Oversaw testing of proprietary fuel management equipment and made recommendations for future use.5. Oversaw field failure diagnostics and recommended courses of action.
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It InternEagle Physicians & Associates, P.A. May 2008 - Aug 2010Greensboro, North Carolina, UsManaged over 30,000 medical records during a transfer between electronic medical record systems.
Caleb Osborne Skills
Caleb Osborne Education Details
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Quantic School Of Business And TechnologyGeneral -
North Carolina State UniversityMechanical Engineering
Frequently Asked Questions about Caleb Osborne
What company does Caleb Osborne work for?
Caleb Osborne works for Asensus Surgical
What is Caleb Osborne's role at the current company?
Caleb Osborne's current role is Director, Product Development.
What is Caleb Osborne's email address?
Caleb Osborne's email address is ca****@****ail.com
What is Caleb Osborne's direct phone number?
Caleb Osborne's direct phone number is +191976*****
What schools did Caleb Osborne attend?
Caleb Osborne attended Quantic School Of Business And Technology, North Carolina State University.
What are some of Caleb Osborne's interests?
Caleb Osborne has interest in Web Development, Medical Devices, Fiction Writing, Alternative Energy Technologies.
What skills is Caleb Osborne known for?
Caleb Osborne has skills like Solidworks, Microsoft Office, Windows, Pro Engineer, Matlab, Regulatory Submissions, Field Trials, Data Analysis, Problem Solving, Lean Thinking, Product Development, Management.
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