Elizabeth (Elli) Marrs Bosek Email & Phone Number

Denver, Co, Us

Minneapolis, Mn, Us

Minneapolis, Mn, Us

• Determine global regulatory strategy to introduce new medical device products as well as implement changes to existing devices for earliest possible approvals.• Collaborate with cross-functional teams to participate in creation and review of key change product development deliverables.• Author regulatory documents, including submissions, license renewal and annual registrations.• Provide support for currently-marketed products, including review of product/ manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling.• Manage all regulatory activities for Medtronic pulse oximetry patient monitoring sensor products.• Ensure compliance with global regulatory agencies, specifically the US and EU.

• Provide analysis of non-conformances and customer complaints for key stakeholder groups. Collaborate with production staff, project engineers, surgical planners and designers to resolve quality issues within the process. Assist in the submission of any applicable reports to designated regulatory agencies.• Review documentation for regulatory submission, including 510k submissions and compiling a technical file.• Develop and continuously improve processes (IQ/OQ/PQ), validations and verifications in accordance with 21 CFR 820, ISO 13485, and AS9100 standards.• Perform software validations of programs including eQMS system, medical imaging and three-dimensional design software.• Support internal and external audits and lead efforts to address findings, resolve gaps and communicate improvements to clients and other invested teams.• Lead the execution of corrective and preventative actions to improve the workflow from case initiation through surgical plan and design to manufacturing and shipment of final patient-specific product.• Communicate with clients to understand specifications and co-develop enhanced workflows to mitigate scrap, ensure manufacturability and ship quality product.• Bring new products to production following a Quality by Design phase-gate approach.• Knowledge of plastic and metal additive manufacturing technologies to produce anatomical models, surgical guides and implantable devices.

Clemson, Sc, Us

Assist professor in grading material from Solidworks 3D CAD modeling course. Team up with other graduate students to delegate tasks and correspond with the professor quickly and efficiently.

Clemson, Sc, Us

Tutor for Clemson University's Programs for Educational Enrichment and Retention (PEER) and Women in Science and Engineering (WISE) department, where our mission is to educate, recruit, and retain underrepresented populations in STEM fields through mentoring, academic coaching, counseling, and academic enrichment. Tutor specifically in the areas of biomedical engineering courses and Solidworks courses. Address varying learning styles, employ efficient communication, and equip students with study skills.

Greenville, South Carolina, Us

Conceptualized a novel intramedullary rib fracture fixation device for undergraduate Senior Design course, which was then selected to continue on to the Master’s capstone course level. Completed a mock FDA 510[k] process, including risk documentation and traceability matrices. Conducted verification and validation testing using finite element analysis simulations and mechanical testing methods, and developed engineering acceptance criteria.Identified clinical and user needs and validated those needs through voice of customer interactions and demonstrations.Collaborated with team members to hit project deadlines and pass critical gates.

Saint Louis, Missouri, Us

Utilize technical engineering background within the Intellectual Property practice group in the preparation and prosecution of patent applications. Solve client challenges and correspond with the U.S. Patent and Trademark Office.

Clemson, South Carolina, Us

Conducted research with CU REPRO team by acquiring implants from local hospitals to analyze the device failure modes and address critical performance variables to improve joint replacement outcomes. Collaborated with faculty and students to foster relationships and critical thinking. Compiled a registry containing results of failure analysis to influence future design inputs.

Clemson, Sc, Us

Conduct energy audits and provide small and medium-sized manufacturers with site-specific recommendations for improving energy efficiency, reducing waste, and increasing productivity through changes in processes and equipment. Complete excel-based data entry and data manipulation and assist with preparation of assessment reports to be submitted to the manufacturing firms and Department of Energy.

Clemson, Sc, Us

Led a health and safety-focused dialogue for first year students to understand campus resources and achieve success at Clemson. Use of interpersonal skills to educate others about preventing danger and promoting well-being in college.

Denver, Colorado, Us

Denver County Ambassador for “Making Colorado” Development Project: interviewing business and community leaders, media outreach projects, brand design. Won video challenge competing against representatives of all 64 counties in the state.

Master Of Engineering - Meng, Bioengineering And Biomedical Engineering

Bachelor’S Degree, Bioengineering And Biomedical Engineering

Bachelor’S Degree, Bioengineering, Concentration In Biomaterials

High School