Tom Baran Email and Phone Number
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Experienced and proven leader with progressive management responsibility spanning global multi-discipline medical device engineering and manufacturing organizations.QUALIFICATIONS Over 25 years of product development experience, including 10+ years of experience developing and manufacturing Class II and III medical devices. Have managed departments of 250+ employees spanning multiple regions (Americas, Europe, APAC) with P&L responsibility exceeding $20MM/yr. Skilled in partnering with senior management to develop and execute strategic plans. Effectively develops and leverages senior level relationships with external partners and internal customers in order to meet financial, strategic, and other organizational goals. Continuous Improvement mindset; experienced in identifying, standardizing, and driving best practices throughout organizations and optimizing processes. Leadership Development focus – extensive experience recruiting, mentoring, and developing engineer, manager, and director-level personnel.TECHNICAL EXPERIENCE Extensive experience with medical device design and manufacturing, including interfacing with disposables, understanding of and compliance to medical device design controls and standards (FDA, 21 CFR Part 820, ISO-13485, IEC 60601-1 / 60601-1-2, cGMP), and coordinating 510k, NDA, and other regulatory agency approvals. Significant experience in Product Lifecycle management, from conceptualization / Proof-of-Concept modeling, design, prototyping, testing/verification, and obtaining regulatory approvals, through NPI (New Product Introduction) / transfer to manufacturing. Extensive knowledge of medical device design standards, risk management, documentation standards (DHF/DMR), and regulatory agency requirements. “Hands-on” experience providing team leadership, mentoring, and technical guidance to staff/co-workers spanning analog, digital, mechanical, software, quality, and systems engineering disciplines. Familiar with most major schematic capture, PCB layout, DFx, mechanical design, and software development tools; also proficient in ERP systems (SAP), Product Lifecycle Management tools (Agile), Requirements Management tools, and all MS Office applications.
United Therapeutics Corporation
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Associate Vice President, Medical Device OperationsUnited Therapeutics Corporation Sep 2021 - PresentSilver Spring, Maryland, Us
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Senior Director, Medical Device OperationsUnited Therapeutics Corporation Mar 2019 - Sep 2021Silver Spring, Maryland, UsOversee all Medical Device Operations activities across US and Europe; Plan, direct, and provide oversight of all engineering efforts for development, manufacturing, and sustaining of medical devices; Evaluate and manage Contract Manufacturing Organizations (CMOs) and service providers; Negotiate contracts and business agreements; Define and implement product roadmaps; Evaluate and integrate technological and process improvements into product lines; Develop a continuous-improvement mindset among staff and external partners; Oversee the recruiting, development, and mentoring of a high-performance, global engineering team.
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Director, Medical Device OperationsUnited Therapeutics Corporation Jun 2018 - Mar 2019Silver Spring, Maryland, UsSelected, developed, and managed supply chain partners to support the company’s clinical and commercially released medical device portfolio; Oversaw the execution of medical device sustaining engineering projects, ensuring that all projects are planned and executed to schedule; Support and mentor department staff on best practices for medical device production and sustaining.
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Director Of Engineering - Medical Device DevelopmentUnited Therapeutics Corporation Aug 2016 - Jun 2018Silver Spring, Maryland, UsPlanned, directed, and implemented all engineering efforts for development and sustaining of the company's medical devices; Recruited, trained, and developed cross-discipline engineering team to ensure business needs were met; Managed external product development and manufacturing partners to ensure continuity of product pipelines.
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Customer Director - Healthcare/Life SciencesPlexus Corp. Nov 2015 - Aug 2016Neenah, Wi, UsOversaw all engineering and manufacturing activities for assigned customers in the Healthcare / Life Sciences market sector; Defined manufacturing and after-market support strategies; Facilitated new product introductions; Cultivated new business opportunities. -
Director Of Project ManagementPlexus Corp. Jun 2011 - Nov 2015Neenah, Wi, UsRecruited, trained, and managed Project Management staff; Prepared and submitted monthly forecasts; Maintained full P&L (~$11M/yr) and customer satisfaction responsibility for all projects under management; Defined and implementing best practices across the global Project Management organization.
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Director Of EngineeringPlexus Corp. Jun 2009 - Jul 2011Neenah, Wi, UsResponsible for ~60 person engineering team composed of Electrical, Software, Mechanical, and Quality engineers and managers; Recruited and mentored staff; Coordinated technical training; Drove Continuous Improvement activities; Managed capital equipment expenditures; Balanced staffing needs in a global and fast-paced matrix environment.
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Engineering Manager / Operations ManagerKimball Electronics Group Aug 2007 - May 2009Responsible for all production and engineering support functions (400+ Indirect and Direct staff) for a 150,000 sq ft electronics manufacturing facility for Class II and III medical devices; Oversaw definition and development of training curriculum for staff; Implemented plant-wide Lean manufacturing concepts; Defined and monitored metrics to measure performance; Improved factory productivity by >30% by implementing operational excellence initiatives.
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Director/Senior Director, Design ServicesJabil Circuit, Inc. Feb 2002 - Jun 2007St Petersburg, Florida, UsResponsible for ~160 person multi-discipline global design engineering staff (US, Europe, and APAC); Maintained full P&L responsibility for all projects under management; Developed long-range strategic plans for department and advised senior management; Defined staffing requirements and initiated recruiting activities; Managed contract negotiations with key customers/vendors. -
Design Engineering ManagerJabil Circuit, Inc. Jun 2000 - Feb 2002St Petersburg, Florida, UsManaged design engineering department of 30+ engineers and support personnel; Reviewed electrical and mechanical designs; Provided technical guidance to both internal and customer staff; Resolved internal and external conflicts; Mentored growth of department personnel; Identified/researched new technologies and how they could be applied in a product development environment.
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Technical Project Manager / Business Unit ManagerJabil Circuit, Inc. Jun 1998 - Jun 2000St Petersburg, Florida, UsGuided two new designs for a major OEM from conceptualization into production; Managed all aspects of the manufacturing business, including Master Scheduling, negotiating Purchase Orders, Materials Management, and complete P&L ownership; Acted as liaison between customer and internal management personnel.
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Test EngineerJabil Circuit, Inc. Aug 1995 - Jun 1998St Petersburg, Florida, UsDesigned and developed test equipment to support testing of production assemblies; Validated designs and design changes in a laboratory environment; Implemented testing algorithms using both hardware and software; Defined custom test and user specifications; Worked closely with both customer and manufacturing personnel in a fast-paced environment to eliminate production hazards and ensure timely delivery of high-quality, defect-free products.
Tom Baran Skills
Tom Baran Education Details
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Florida State UniversityElectrical And Electronics Engineering -
Florida State UniversityElectrical And Electronics Engineering
Frequently Asked Questions about Tom Baran
What company does Tom Baran work for?
Tom Baran works for United Therapeutics Corporation
What is Tom Baran's role at the current company?
Tom Baran's current role is Associate Vice President, Medical Device Operations at United Therapeutics Corporation.
What is Tom Baran's email address?
Tom Baran's email address is to****@****xus.com
What is Tom Baran's direct phone number?
Tom Baran's direct phone number is +192072*****
What schools did Tom Baran attend?
Tom Baran attended Florida State University, Florida State University.
What are some of Tom Baran's interests?
Tom Baran has interest in Water Sports, Children, Education, Reading, Classic Ford Mustangs, Outdoors Activities, Fishing.
What skills is Tom Baran known for?
Tom Baran has skills like Manufacturing, Engineering Management, Engineering, Product Development, Electronics, Cross Functional Team Leadership, Testing, Lean Manufacturing, Design For Manufacturing, Continuous Improvement, Project Management, Root Cause Analysis.
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