Danielle Marks Email & Phone Number

Chicago, Il, Us

Naperville, Illinois, Us

Naperville, Illinois, Us

Key technical leader and contributor to the R&D team. Lead development and design verification projects to implement product improvements and support PROACTIVE-HF and SIRONA II clinical trials.• Directed multi-disciplinary team in development of next generation Calibration Equipment from project definition through feasibility, verification, submission and FDA approval for use in pre-market investigational device exempt (IDE) study • Planned and executed design verification testing for handheld and mobile medical electrical equipment with embedded software following IEC 60601-1 performance standards• Provided technical support in the field for human clinical trials in US (PROACTIVE-HF IDE Trial), Ireland (Sirona First-in-Human Pilot Trial), and Belgium (Sirona II CE Mark Trial)• Supported GLP animal study through manufacture of test articles and data collection at various study end points • Supported ISO 13485:2016 certification by coordinating document requests during multi-day on-site BSI audit • Performed sustaining engineering tasks such as training manufacturing, process improvements, evaluating for impact of supplier change notifications, root cause analysis, and non-conforming materials and CAPA investigations• Performed Hazard Analyses and FMEA (Failure Mode and Effects Analysis) per ISO 14971 for both existing and newly developed medical devices

Evanston, Il, Us

The BME Advisory Board is comprised of industry and academic leaders and Northwestern alumni and provides guidance and advice to assist the BME department to support and strengthen its goals and better serve its students.

Franklin Lakes, New Jersey, Us

Provided Research & Development expertise to identify, design, implement and sustain new products/processes. Served as Project and Technical Leader for a new product development where I managed concept generation, design requirement establishment, test method development, FMEA and verification & validation strategy/execution, clinical evaluation report & 510(k) submission, design transfer and commercialization. Responsibilities included:• Lead multi-disciplinary teams including manufacturing, marketing, and quality through project scoping, design, development, verification, validation and commercialization.• Work closely with manufacturing plants and third party vendors during prototyping, product builds and design transfer. • Develop and implement project schedules. • Work with functional experts to understand and/or challenge product requirements. • Collaborate with marketing to obtain voice of customer and identify user needs. • Conduct and/or facilitate feasibility, verification and validation testing. • Document all the necessary project activities in accordance with our design control and stage & gate processes.

Evanston, Il, Us

Served as an undergraduate researcher within the Molecular Modeling of Biomaterials Group directed by Professor Igal Szleifer.• Conducted finite-element drug release simulations to determine validity for intravaginal ring design • Computationally analyzed trajectories describing the mobility of HIV viral particles diffusing in cervical mucus • Performed Partial Wave Spectroscopy (PWS) microscope procedures for early cancer screening trials• Collaborated with group of 14 graduate students and postdoctoral fellows during weekly lab meetings

Northfield, Il, Us

Supported R&D activities for the Microbiology team• Strategized and executed experiments for patent-pending antimicrobial products • Presented research findings and issued a recommendation for next actions to the Executive Team• Revised protocol on proper Anaerobic Chamber operating procedures• Trained on GLP, Lab Safety, Compliance, Ethics

Bachelor Of Science, Biomedical Engineering, Global Health Studies Minor

Education record