Mitch Johnson work email
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Mitch Johnson personal email
President and founder of Novanel Engineering, providing solutions in regulatory affairs to wearable health technology companies. My experience leading regulatory affairs and product development allows me to succeed where others cannot – I bring solutions that allow regulatory compliance along with faster product development. I support all levels of organizations, providing executive level insight as well as hands-on solutions. I provide guidance on design controls, regulatory affairs strategy, software compliance, risk management, human factors engineering, verification and validation, technical file preparation, prepare submissions for marketing authorization and will help you respond to that 483 sitting on your desk. I have deep expertise in hearing aids and FDA OTC over-the-counter regulation. I am passionate about exploring new ideas, finding elegant solutions, and mentoring and developing the next generation of leaders within the medical device industry.
Novanel Engineering
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PresidentNovanel Engineering Mar 2023 - PresentNovanel Engineering provides broad medical device leadership to all levels of your organization from executive insight to development leadership. Adding value in broad disciplines of Design Controls, Regulatory Affairs & Strategy, Software Compliance, Risk Management, Human Factors, Verification & Validation, Technical file preparation, Biological Safety Assessment.
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Senior Director Of Research And DevelopmentIntricon Corp Sep 2019 - Dec 2022Arden Hills, Mn, UsDirects corporate research and development teams working in multiple geographic locations to research new technologies and develop new medical devices intended for sale and distribution via OEM as well as direct to customers. Initiates, drives and executes new product development efforts utilizing customer feedback and business/technology research. Develops and implements multi-year strategic product development plans to support business growth targets. Develops and manages intellectual property for the protection and advancement of business strategies. Performs due diligence activities related to prospective acquisitions and partnerships. -
Director Regulatory AffairsIntricon Corp Aug 2014 - Sep 2019Arden Hills, Mn, UsBears corporate responsibility for Regulatory Affairs and compliance. Company liaison with FDA, European Notified Bodies, and other medical device regulatory agencies. Identifies & directs regulatory paths for new product compliance in IntriCon's strategic markets. Ensures compliance with new and existing products by establishing appropriate corporate systems. Communicates & translates regulatory requirements to corporate staff. Also responsible for oversight of corporate Intellectual Property.
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Director, Product Development (Cdm & Pada)Intricon Corp Jun 2013 - Aug 2014Arden Hills, Mn, UsContinuing responsibility for professional audio products and acquired responsibility for Cardiac Diagnostic Monitoring product development. Managed corporate Intellectual Property.
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Global Director, Product Development (Pada)Intricon Corp Jul 2010 - Jun 2013Arden Hills, Mn, UsGlobal responsibility for the development of Professional Audio Devices and Accessories (PADA), products, strategies and technologies.
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Director Product DevelopmentIntricon Corp Jan 2001 - Jul 2010Arden Hills, Mn, UsDirects product development strategy & execution. Responsible for conceptualization, design, development of professional microphones, headsets, and audio communications systems.
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Manufacturing & Project ManagerIntricon Corp Feb 1999 - Jan 2001Arden Hills, Mn, UsRecruited to manage the manufacturing operations and manufacturing projects related to microphone capsules in a newly acquired plant in Singapore, to build teams and drive company revenues.
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Laboratory ManagerW. L. Gore & Associates Apr 1998 - Nov 1998Newark, Delaware, UsManaged the Engineering/Reliability Laboratory supporting electronic and medical product development and manufacturing. -
Test Systems ManagerIntricon Corporation 1996 - 1998Arden Hills, Mn, UsManaged the Test Systems Group in designing, developing, validating, and maintaining automated functional test stations.
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Customer Service Engineering CoordinatorIntricon Corporation 1990 - 1996Arden Hills, Mn, UsActed as technical liaison between RTI’s customers and operations group to coordinate product complaint investigation and resolution. Continued to perform all previous Test Engineering and Test Engineering Leadership functions
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Test EngineerIntricon Corporation 1986 - 1990Arden Hills, Mn, UsDesigned tooling, selected instrumentation, and wrote software for custom automated test equipment that performed final electro-mechanical inspection of volume controls and switches.
Mitch Johnson Skills
Mitch Johnson Education Details
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University Of MinnesotaBachelor Mechanical Engineering
Frequently Asked Questions about Mitch Johnson
What company does Mitch Johnson work for?
Mitch Johnson works for Novanel Engineering
What is Mitch Johnson's role at the current company?
Mitch Johnson's current role is President @ Novanel Engineering | Medical Devices | Regulatory Affairs | Product Development.
What is Mitch Johnson's email address?
Mitch Johnson's email address is mj****@****con.com
What schools did Mitch Johnson attend?
Mitch Johnson attended University Of Minnesota.
What are some of Mitch Johnson's interests?
Mitch Johnson has interest in Photography, Music, Travel, People.
What skills is Mitch Johnson known for?
Mitch Johnson has skills like Manufacturing, Product Development, Testing, Design Of Experiments, Project Management, Product Management, Electronics, Engineering, Iso 14971, Iso 13485, U.s. Food And Drug Administration, R&d.
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