Dan Tylutki

Dan Tylutki Email and Phone Number

Chief Operating Officer @ Cardiac Insight, Inc.
Issaquah, WA, US
Dan Tylutki's Location
Issaquah, Washington, United States, United States
Dan Tylutki's Contact Details

Dan Tylutki personal email

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Dan Tylutki phone numbers

About Dan Tylutki

A leader with an MSEE and over 30 years of experience in product development management and project management, medical device quality systems and regulatory affairs, company management. I have worked at a Fortune 500 firm as well as small entrepreneurial businesses. I have experience doing this in regulated industries including medical devices (FDA, class II/III) and telecommunications (FCC). I am productive, dependable and focused on delivering results.Specialties: • Medical Device Industry• Entrepreneurial / Start–up Environments• Quality Assurance• Regulatory Affairs• Product Development / Project Management• Experienced in managing technology development with OEM vendors• Level-headed problem solver, troubleshooter • Interacts productively with technicians to CEOs • High productivity• High dependability

Dan Tylutki's Current Company Details
Cardiac Insight, Inc.

Cardiac Insight, Inc.

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Chief Operating Officer
Issaquah, WA, US
Dan Tylutki Work Experience Details
  • Cardiac Insight, Inc.
    Chief Operating Officer
    Cardiac Insight, Inc.
    Issaquah, Wa, Us
    View
  • Cardiac Insight, Inc.
    Chief Operating Officer
    Cardiac Insight, Inc. Oct 2022 - Present
    United States
    Responsible for general operations of the company, including manufacturing, customer support, facilities, regulatory compliance, and quality functions.
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  • Cardiac Insight, Inc.
    Vp Of Quality Assurance & Regulatory Affairs
    Cardiac Insight, Inc. Oct 2014 - Sep 2022
    Kirkland, Wa
    Responsible for global regulatory affairs and quality systems for the business. Oversee and maintain all aspects of the quality management system (QMS). Provide QA & regulatory guidance and project deliverables to new product development teams and manufacturing operations.Collaborate closely with executive team to define the strategic direction of the QMS and product regulatory strategies. Prepare and submit product submissions for regulatory agency clearance and approval. Manage FDA inspections and ISO facility audits.
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  • (Self-Employed)
    Project Manager Consultant - Medical Device Development
    (Self-Employed) Oct 2011 - Aug 2014
  • Light Sciences Oncology
    Director, Engineering R&D
    Light Sciences Oncology Mar 2009 - Oct 2011
    Worked with executive team as a technical expert to detemine strategies, timelines and budgets to meet corporate goals. Planned engineering programs, coordinated and managed internal and external project staff to specific phases and aspects of programs.
  • Northstar Neuroscience
    Sr Manager, Software And Mfg Test Engineering / Project Manager
    Northstar Neuroscience Apr 2006 - Jan 2009
    Senior Manager, Software and Test Engineering (2008 - 2009): Managed the day to day Software Engineering and Manufacturing Test Engineering groups’ activities - coordination, planning, and execution. Managed product development projects. Ensured the correctness of project plans as they applied to the groups’ activities, that projects were adequately resourced and that schedules and budgets were met. Coordinated with team members and managers to ensure necessary mid-course corrections were made. Facilitated communications between team members and management.Project Manager, Product Development (2006 - 2008):Led a cross-functional project team in commercializing a Class III medical device system with strict adherence to FDA Design Controls (QSR).
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  • Bally Technologies / Mindplay Llc.
    Director, Product Engineering
    Bally Technologies / Mindplay Llc. Feb 2003 - Apr 2006
    Guided a six person development team in the creation of player tracking systems for Blackjack and Baccarat. Functions managed included software, mechanical and hardware engineering.
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  • Harris Corp. / Wavtrace Inc.
    Senior Manager / Engineering Project Mgr / Test Engineering Manager
    Harris Corp. / Wavtrace Inc. Nov 1997 - Jan 2003
    Senior Manager, System Integration / Design Verification Test (2000 - 2003)• Guided a team of seven new engineers through the process of design verification of a millimeter-wave multipoint broadband access system. Included test for conformance to internal product requirements and specifications as well as telecommunications industry standards and recommendations (Bellcore/Telcordia, ITU-T, ATM Forum, IETF), reliability and environmental targets, regulatory agency requirements (FCC, ETSI).Engineering Project Manager (1998 – 2000)• Managed elements of Wavtrace’s 1st generation millimeter-wave multipoint broadband access system when project timelines slipped significantly. • Project managed the development of Wavtrace’s 2nd generation millimeter-wave multipoint broadband access system. Test Engineering Manager (1997 – 2000)Developed and implemented complete production test strategy for Wavtrace’s 1st generation millimeter-wave multipoint broad band access system.
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  • Varian Medical Systems
    Various Positions Held
    Varian Medical Systems Jan 1985 - Oct 1997
    Gained experience in personnel management, project management, production and operations support and international field service. Positions held: Test Engineering Manager, Senior Test Engineer, Senior Product Support Engineer, Manufacturing Test Engineer
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Dan Tylutki Skills

Cross Functional Team Leadership Product Management Program Management Product Development Fda Telecommunications Integration Design Control Medical Devices R&d U.s. Food And Drug Administration Engineering Management Testing Manufacturing Quality System Troubleshooting Quality Assurance Project Management Research And Development Clinical Trials Clinical Research

Dan Tylutki Education Details

Frequently Asked Questions about Dan Tylutki

What company does Dan Tylutki work for?

Dan Tylutki works for Cardiac Insight, Inc.

What is Dan Tylutki's role at the current company?

Dan Tylutki's current role is Chief Operating Officer.

What is Dan Tylutki's email address?

Dan Tylutki's email address is da****@****ogy.com

What is Dan Tylutki's direct phone number?

Dan Tylutki's direct phone number is +120659*****

What schools did Dan Tylutki attend?

Dan Tylutki attended University Of Idaho, Santa Clara University.

What skills is Dan Tylutki known for?

Dan Tylutki has skills like Cross Functional Team Leadership, Product Management, Program Management, Product Development, Fda, Telecommunications, Integration, Design Control, Medical Devices, R&d, U.s. Food And Drug Administration, Engineering Management.

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