Alyssa Bailey Email and Phone Number
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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.
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Director Of Product DevelopmentInnoblative Designs, Inc. Sep 2021 - PresentChicago, 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. -
Product Development ManagerInnoblative Designs, Inc. Aug 2017 - Sep 2021Chicago, 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 -
Product Development EngineerInnoblative Designs, Inc. Sep 2015 - Aug 2017Chicago, Illinois, UsResponsible for product and test method development for a medical device company focused on developing devices that precisely deliver energy to treat diseased tissue. -
Director Of Research DevelopmentMadison 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
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Research And Development EngineerCook Medical Jan 2012 - Sep 2015Bloomington, Indiana, UsAs 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. -
Piano TeacherSelf-Employed Piano Instructor Sep 2003 - Aug 2015I 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.
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Research And Design Co-OpEthicon Endo-Surgery May 2011 - Aug 2011I 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.
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Research And Design Co-OpEthicon Endo-Surgery Aug 2010 - Dec 2010I 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.
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Research AssistantUniversity Of Michigan May 2009 - Oct 2010I 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.
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Day Camp Team LeaderLiving Water Ministries Jun 2008 - Aug 2008I 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.
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Day Camp CounselorLiving Water Ministries Jun 2007 - Aug 2007I 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
Alyssa Bailey Education Details
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University Of MichiganBiomedical Engineering -
University Of Illinois ChicagoBusiness 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..
What is Alyssa Bailey's email address?
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What is Alyssa Bailey's direct phone number?
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What schools did Alyssa Bailey attend?
Alyssa Bailey attended University Of Michigan, University Of Illinois Chicago.
What are some of Alyssa Bailey's interests?
Alyssa Bailey has interest in Casinos, Collecting Antiques, Exercise, Sweepstakes, Home Improvement, Reading, Gourmet Cooking, Sports, Watching Basketball, The Arts.
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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