Alyssa Bailey Email & Phone Number

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.

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

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.

- 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

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.

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.

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.

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.

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.

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.

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.

Bachelors Of Science, Biomedical Engineering

Master Of Business Administration (Mba), Business Analystics And Entrepreneurship