Mark Dallara

Mark Dallara Email and Phone Number

Quality and Regulatory Director @ AdaptivEndo, LLC
Louisville, KY, US
Mark Dallara's Location
Louisville Metropolitan Area, United States, United States
About Mark Dallara

Engineer and manager with 27 years of experience, including medical device research & development, and production management for motorsport, aerospace, and defense clients.Strong critical thinker and technical communicator with a focus on rational project management, robust design and analysis techniques, rigorous application of engineering fundamentals, and lean manufacturing and development processes.Specialties: - Design, development, and production within certified quality systems- Rational project management using Theory of Constraints- Root cause analysis- Design and process risk management- Reliability (Weibull) analysis- Six Sigma mechanical tolerance optimization- Design for Manufacturing and Assembly (DFMA)- Solid modeling, engineering drawing, and Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.*- Finite Element Analysis (FEA)

Mark Dallara's Current Company Details
AdaptivEndo, LLC

Adaptivendo, Llc

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Quality and Regulatory Director
Louisville, KY, US
Website:
adaptivendo.com
Employees:
19
Mark Dallara Work Experience Details
  • Adaptivendo, Llc
    Quality And Regulatory Director
    Adaptivendo, Llc
    Louisville, Ky, Us
  • Adaptivendo, Llc
    Quality & Regulatory Director
    Adaptivendo, Llc Mar 2023 - Present
    Louisville, Kentucky, Us
  • Freudenberg Medical
    Design Assurance Engineering Manager
    Freudenberg Medical Mar 2019 - Mar 2023
    Beverly, Massachusetts, Us
  • Freudenberg Medical
    Principal Product Development Engineer
    Freudenberg Medical Aug 2018 - Mar 2019
    Beverly, Massachusetts, Us
  • Freudenberg Medical
    Senior Design Engineer
    Freudenberg Medical Apr 2015 - Jul 2018
    Beverly, Massachusetts, Us
  • Dallara Llc
    Production Manager
    Dallara Llc Feb 2011 - Apr 2015
    Varano De’ Melegari, Italy, It
    Responsibilities:• Direction of production planning and assembly, composites, and fabrication manufacturing cells.• Safety program manager and key member of the quality system development team.• Administration of production planning data and workflow in the internally-developed ERP system.Key achievements:• Maintained production schedule and inventory levels of internally produced and locally subcontracted chassis components for 2012-2014 Indycar seasons and instituted the use of consumption trend analysis as a key input.• Collaborated with colleagues at Dallara Automobili headquarters in Italy and local general contractors to plan and execute construction and expansion of 30,000 sq ft plant.• Improved production planning portions of enterprise resource planning system through rigorous application of system tools and detailed algorithm analysis, bug reporting, and workflow feature requests to Italian development team.• Developed project plans for special orders from aerospace clients and conducted postpartum reviews.• Established and maintained procedures for safety and facility security as part of OSHA and ITAR compliance, and quality system procedures for ISO 9001 registration, as a prerequisite for a defense industry client.
  • Conmed Linvatec
    Principal Engineer / Group Manager
    Conmed Linvatec 2005 - 2010
    Largo (Tampa Bay), Fl, Us
    Responsibilities:• Direction, staffing, and budgeting of a research group performing in-depth analysis of product failures with critical business and/or regulatory implications.• Ensure feedback of lessons learned from failure analyses to design, reliability, and risk management practices.Key achievements:• Created the Engineering Analysis group with the Vice President of R&D to obtain more detailed and accurate information from product failures; established its vision, methods, and operating principles.• Contributed to the achievement of the division’s reliability goal of a 10% reduction in the average weighted complaint rate for key products each year for three consecutive years.• Performed a gap analysis of departmental practices of reliability specification, testing, and analysis; published internal guidance on the correct application of Weibull distributions and related statistical techniques.• Overhauled the company’s risk management process to achieve compliance with ISO 14971 and add more value to the product development process in an efficient manner.
  • Conmed Linvatec
    Senior Engineer, Power Tools R&D
    Conmed Linvatec 2004 - 2005
    Largo (Tampa Bay), Fl, Us
    Key achievements:• Developed the PRO2033 high speed drill attachment for the PowerPro handpiece line as lead design engineer and project manager of a cross-functional team.• Analyzed failures of legacy handpieces and attachments, including several gearbox and bearing configurations; published internal lessons-learned summaries.• Authored the company’s first internal procedure governing technical drawings to customize ASME Y14 standards and prevent recurrent problems in development projects.
  • Conmed Linvatec
    Engineer
    Conmed Linvatec 1999 - 2004
    Largo (Tampa Bay), Fl, Us
    Key achievements:• Successfully led a variety of new sports medicine products from concept through market launch to post-market surveillance as design engineer and project manager of cross-functional teams.• Invented and developed the BioStinger Hornet delivery system for a bioabsorbable meniscal repair implant.• Developed the Stress-Equalizing Graft Tensioning System in conjunction with the surgeon inventor; revised design for usability, manufacturability, cleanability, and accuracy. U.S. patent #7686810.• Invented an expanding dilator system for compacting bone tunnels in anterior cruciate ligament repair. U.S. patent #7211098.
  • Intervascular
    Engineer
    Intervascular 1997 - 1999
    Key achievements:• Designed and developed multiple iterations of the stent portion of prototype endovascular prosthesis systems for minimally invasive abdominal aortic aneurysm repair. U.S. patents #6802859, #7122051.• Directed in vitro stent durability testing and radial force measurement as part of design verification, including equipment specification and qualification, protocol development, testing, and data analysis.
  • Johnson & Johnson Medical
    Engineer
    Johnson & Johnson Medical 1996 - 1997
    New Brunswick, Nj, Us
    Key achievements:• Directed the technical effort to demonstrate compliance with domestic and international harmonized standards, supporting CE Mark Declarations of Conformity for non-invasive blood pressure (NIBP) cuff systems.• Established the strategic approach to risk analysis for NIBP accessories.

Mark Dallara Education Details

  • The University Of Memphis
    The University Of Memphis
    Biomedical Engineering
  • University Of Florida
    University Of Florida
    Engineering Science (Biomechanics)

Frequently Asked Questions about Mark Dallara

What company does Mark Dallara work for?

Mark Dallara works for Adaptivendo, Llc

What is Mark Dallara's role at the current company?

Mark Dallara's current role is Quality and Regulatory Director.

What is Mark Dallara's email address?

Mark Dallara's email address is ma****@****cal.com

What is Mark Dallara's direct phone number?

Mark Dallara's direct phone number is +121296*****

What schools did Mark Dallara attend?

Mark Dallara attended The University Of Memphis, University Of Florida.

Who are Mark Dallara's colleagues?

Mark Dallara's colleagues are Trevor Powers, Bryan Brown, Tim Furnish, Walter Stubblefield, Nicholas Canfield, Dustin Stivers.

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