Alyssa Bailey

Alyssa Bailey Email and Phone Number

Director of Product Development at Innoblative Designs, Inc. @ Innoblative Designs, Inc.
Alyssa Bailey's Location
Greater Chicago Area, United States, United States
Alyssa Bailey's Contact Details

Alyssa Bailey personal email

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About Alyssa Bailey

My biggest asset in the medical device industry is my understanding of the technical, clinical, regulatory, and business requirements of a project, and most importantly, that all of those requirements must harmonize. With over a decade of experience in the medical device industry, I've worked for large companies and start-ups, and no matter the size, I found the biggest challenge companies face is the ability to marry those four distinct and often competing needs. These requirements are true of any product development, but especially important in the complex world of medical devices where technology is always changing and adapting, clinical needs are often varied and complicated, and regulatory clearance isn't always a straight forward path.

Alyssa Bailey's Current Company Details
Innoblative Designs, Inc.

Innoblative Designs, Inc.

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Director of Product Development at Innoblative Designs, Inc.
Alyssa Bailey Work Experience Details
  • Innoblative Designs, Inc.
    Director Of Product Development
    Innoblative Designs, Inc. Sep 2021 - Present
    Chicago, Illinois, Us
    • Manages the company's engineering and product development teams.• Provides scientific and technical strategy to Innoblative’s management team and board.• Works closely with the VP of Regulatory and Quality to ensure the engineering team’s work is in accordance with regulatory and quality standards.• Manages the engineering project schedules and budget. Makes financial choices for the engineering team based on project priority and schedule demands.• Develops a business plan and budget required to execute an annual and multi-year R&D plan.• Manages the supply chain and purchasing department. • Identifies, communicates, and manages risks.• Directs the efficient use of resources to effectively complete projects.• Assists the CTO in developing business strategies that result in mapping/planning of present and future product development efforts. Develops and maintains pertinent project lists, including periodic project ranking and the development of the product portfolio.• Provides support as required to safety, ISO, FDA, corporate and internal audits.• Manages or oversees the management of the supply chain for the company’s products.• Manages or oversees the management of the manufacturing partners.• Ensures adequate lab space, equipment, and other resources are available to the engineering team in order for meet project objectives.• Supports clinical and scientific reporting for regulatory submissions and scientific communications.• Develops and maintains relationships with thought leaders in the scientific community.• Attends and participates in regional, national, and international scientific meetings.
  • Innoblative Designs, Inc.
    Product Development Manager
    Innoblative Designs, Inc. Aug 2017 - Sep 2021
    Chicago, Illinois, Us
    - Responsible for the testing development, documentation, authoring of the regulatory submissions, and ultimate 510(k) clearance and CE Mark of the company's first product- Presented directly to the FDA, answering questions and understanding their concerns during the clearance process- Responsible for researching and vetting new manufacturing partners- Responsible for negotiating the contract for a new office space, as well as all the logistics of moving the company to a new location- Authored and managed abstract submissions to scientific conferences- Met with strategic partners to learn about their technical needs and potential partnerships- Managed all GLP testing, including authoring and reviewing pre-clinical protocols and reports- Maintained relationships with KOLs and interviewed them to determine future market needs for pipeline projects- Created and managed the multimillion dollar budget for the engineer department
  • Innoblative Designs, Inc.
    Product Development Engineer
    Innoblative Designs, Inc. Sep 2015 - Aug 2017
    Chicago, Illinois, Us
    Responsible for product and test method development for a medical device company focused on developing devices that precisely deliver energy to treat diseased tissue.
  • Madison Scientific
    Director Of Research Development
    Madison Scientific Dec 2020 - Aug 2021
    - Led the team to develop market and product specifications- Performed thorough IP search to determine which elements of the design were eligible and worth protecting, as well as what elements are at risk due to existing IP- Served as an independent reviewer at design reviews - Managed grant submissions, including writing the technical submission and creating the budget for the project in adherence to NSF guidelines- Regularly consulted with doctors to determine the technical specifications and needs of the product
  • Cook Medical
    Research And Development Engineer
    Cook Medical Jan 2012 - Sep 2015
    Bloomington, Indiana, Us
    As a Research and Development Engineer, I design and develop class three medical device products. As project leader I am responsible for the development of products from initial feasibility to an approved manufactured product, by working with engineering, manufacturing, regulatory, quality assurance, and marketing staff. I contribute to the intellectual property of the company via invention disclosures and patent applications. I also maintain and expand my medical device and procedural knowledge by meeting with physicians, viewing cases, and staying up to date on the current state of relevant medical conditions and procedures.
  • Self-Employed Piano Instructor
    Piano Teacher
    Self-Employed Piano Instructor Sep 2003 - Aug 2015
    I marketed myself to the community to provide piano lessons. I taught a variety of students, from the ages of five to fifty. I started giving lessons at my home and later also taught at Music Box Studios.
  • Ethicon Endo-Surgery
    Research And Design Co-Op
    Ethicon Endo-Surgery May 2011 - Aug 2011
    I helped the team design the next generation Harmonic ultrasonic cutting and coagulating surgical device. I used FEA, CAD modeling, rapid prototyping tools, FMEA, and statistical analysis to support the design process.
  • Ethicon Endo-Surgery
    Research And Design Co-Op
    Ethicon Endo-Surgery Aug 2010 - Dec 2010
    I helped the team design the next generation gastric band and a new staple cartridge for use with the Echelon Endocutters. I used FEA, CAD modeling, rapid prototyping tools, FMEA, and statistical analysis to support the design process.
  • University Of Michigan
    Research Assistant
    University Of Michigan May 2009 - Oct 2010
    I examined the effects of manipulated diet and exercise on bone quality. Responsible for microscopic analysis and histology preparation. I used ELISAs, Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES), mechanical testing with the Admet Expert 450, and micro-CT scanning for the research. BMES Conference 2010, ORS Conference 2011.
  • Living Water Ministries
    Day Camp Team Leader
    Living Water Ministries Jun 2008 - Aug 2008
    I was promoted from Day Camp Counselor to Day Camp Team Leader. Responsible for all camp participants, event planning and coordination, and communicating with churches and staff.
  • Living Water Ministries
    Day Camp Counselor
    Living Water Ministries Jun 2007 - Aug 2007
    I was responsible for the safety and well-being of the children at the camp. I lead group activities, handled any problems that occurred, and served as a mentor to the children and young adults.

Alyssa Bailey Skills

Biomedical Engineering Medical Devices Data Analysis Matlab Research And Development Statistics Microsoft Office R&d Solidworks Research Analysis Teaching Finite Element Analysis Minitab Design Of Experiments Event Planning Cell Culture Public Speaking Life Sciences Labview Cad Teamwork Lifesciences Powerpoint Prototyping Catheter Lab Experience Animal Lab Experience Early Feasibility Design Work Technical Writing

Alyssa Bailey Education Details

  • University Of Michigan
    University Of Michigan
    Biomedical Engineering
  • University Of Illinois Chicago
    University Of Illinois Chicago
    Business Analystics And Entrepreneurship

Frequently Asked Questions about Alyssa Bailey

What company does Alyssa Bailey work for?

Alyssa Bailey works for Innoblative Designs, Inc.

What is Alyssa Bailey's role at the current company?

Alyssa Bailey's current role is Director of Product Development at Innoblative Designs, Inc..

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What schools did Alyssa Bailey attend?

Alyssa Bailey attended University Of Michigan, University Of Illinois Chicago.

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What skills is Alyssa Bailey known for?

Alyssa Bailey has skills like Biomedical Engineering, Medical Devices, Data Analysis, Matlab, Research And Development, Statistics, Microsoft Office, R&d, Solidworks, Research, Analysis, Teaching.

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