Kalley Berg
Program Engineer II at Nuwellis, Inc.- Claim this Profile
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Spanish Native or bilingual proficiency
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Bio
Experience
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Nuwellis, Inc.
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Program Engineer II
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Dec 2022 - Present
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Development Engineer II
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Apr 2022 - Dec 2022
Led core team and technical team meetings with cross-functional team members working on new development products. Represented functions included engineering (software, hardware, mechanical), marketing, regulatory, design assurance and executive management. Created and released the mechanical requirements documentation for a new product in development. Used customer, product, and technical specifications to develop concise and testable requirements. Mentored and provided direction to two interns and one new graduate. Gave work direction, answered questions, and checked in on individuals as needed, was responsible for guidance towards successful completion of tasks and projects.Provided demonstrations to physician and nursing advisory boards, executive management and key stakeholders to seek feedback and input multiple times during product development. Led design efforts for disposable circuits, including initial design, characterization testing, sterilization validation, design for manufacturing, manufacturing documentation creation, biocompatibility testing, and more. Worked with vendors both locally and internationally, to design and source custom disposable components. Managed outside consultants and their contributions to the development effort, including industrial designers, mechanical and electrical engineers, and software developers. Show less
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Development Engineer
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Apr 2021 - Apr 2022
Key contributor to developing a functional prototype of an electro-mechanical integrated system in a new development project. Managed and lead cross functional and international team in working together to bring a new product to market.
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University of Minnesota Department of Biomedical Engineering
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Higher Education
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1 - 100 Employee
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Directed Research-Cardiac ICU-OR Ergonomic Improvement
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Jan 2021 - Apr 2021
Working on ergonomic improvements to the cardiac OR/ICU transfer process. Performing voice of customer interviews and observation to identify needs and the prototyping design solutions. Working on ergonomic improvements to the cardiac OR/ICU transfer process. Performing voice of customer interviews and observation to identify needs and the prototyping design solutions.
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Treasurer
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May 2020 - Apr 2021
• Responsible for planning and budgeting for 12 committees with 60 leadership team members • Overseeing and managing budget reduction from $60,000 to $30,000 due to funding reductions as a result of COVID-19 crisis. • Maintained cash flow/ledger for Fiscal Year 21. • Worked with Corporate Partners to coordinate sponsorship, through invoicing and communication. • Oversaw and maintained records for 501(c)3 organization. • Responsible for planning and budgeting for 12 committees with 60 leadership team members • Overseeing and managing budget reduction from $60,000 to $30,000 due to funding reductions as a result of COVID-19 crisis. • Maintained cash flow/ledger for Fiscal Year 21. • Worked with Corporate Partners to coordinate sponsorship, through invoicing and communication. • Oversaw and maintained records for 501(c)3 organization.
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Smiths Medical
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United States
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Medical Device
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700 & Above Employee
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R&D Intern
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May 2020 - Jan 2021
• Followed Structure Development Process (SDP) to create detailed work breakdown structures for functional groups including: Risk Management, Human Factors Engineering, System/Product Integration, Design Transfer, Software Development, Electrical Engineering Development, Packaging, Labeling, Biocompatibility and Sourcing and Supply Chain. • Integrated functional group steps into a Gantt Chart, defining predecessors and successors for key inputs, outputs, and deliverables for each functional group step. • Experienced in Project Management activities including creating slide decks for gate reviews, identifying resource needs, and exposure to gate review meetings Show less
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Accenture
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Ireland
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Business Consulting and Services
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700 & Above Employee
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Contractor
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Jul 2019 - Jun 2020
Data analytics and clean up. Data analytics and clean up.
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InSitu Technologies® Inc.
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Intern
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Mar 2019 - Aug 2019
Engineering Intern Worked on the creation and completion of a medical device technical file for submission to FDA and the design dossier for CE marking of a class III device. Created templates for test protocols and reports for continual use. Created and contributed to high-level technical documentation including Risk Management Files, Usability Files, and Phase Approvals. Assisted in preparing for MDSAP Audit. Conducted data analytics and bench testing on various devices. Wrote a plan and determined strategy for software validation of internal software, including IQ/OQ/PQ. Received knowledge on many aspects of a medical device company including R&D, Quality Assurance, Regulatory Affairs and Customer Service. Show less
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Office Assitant
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Sep 2018 - May 2019
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Lakes International Language Academy
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United States
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Primary and Secondary Education
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1 - 100 Employee
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Explorer Club Aide
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Apr 2015 - Dec 2018
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Tutor
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Nov 2016 - Aug 2017
Tutor ages Kindergarten to Adult in all subjects. Tutor ages Kindergarten to Adult in all subjects.
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Education
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University of Minnesota
Bachelor's degree, Biomedical Engineering -
Forest Lake Senior High School
High School Diploma