Kristen Maynard Email & Phone Number

Saint Paul, MN, US

Marlborough, MA, US

Marlborough, MA, US

Marlborough, MA, US

• Utilized Cognition Cockpit Requirements Management System to author and update Risk Management deliverables (Design FMEA, Task Analysis, Hazard Analysis) for three Prosthetic Urology product lines.
• Used expertise risk management processes and Cognition Cockpit experience to guide cross-functional project teams in assessing the impact of design and process requirement changes on risk management deliverables to.
• Streamlined complaints analysis process used by Design Quality Assurance, leading to improved consistency and reduced time needed to trace complaints to Risk Management documentation.
• Analyzed feedback via complaints and public information to assess the quality, safety, and performance of Prosthetic Urology Products as part of the Post-Market Surveillance process.
• Closely collaborated with the Complaint Management Center in evaluating signals of concern originating from complaint trending and monitoring.

Marlborough, MA, US

• Managed technical reviews, dispositions, and document approvals for 40+ deliverables, supporting the transition from American Medical Systems (AMS) to BSC risk management processes and the remediation of Design History.
• Worked with a team of Quality, Research and Development, and Process Engineers to use the Cognition Cockpit in developing and maintaining ISO 14971 compliant risk management files, including Design and Process Failure.

Lake Elmo, Minnesota, US

• Supported Quality Engineers and Managers in the completion of risk documentation files, including risk management plans and Failure Modes and Effects analyses (FMEAs).
• Authored and revised Quantitative Risk Management Process (QRMP) documentation, including policies, procedures, work instructions, and data capture forms.
• Managed and facilitated scheduling of working sessions for Quality Engineers and Subject Matter Experts.

New York, NY, US

• Provided proofreading services to non-native English speakers and ensured correct grammar, punctuation, and terminology use in scientific manuscripts accepted for publication.

• Key player in review and analysis of the Corrective and Preventative Action (CAPA) Portfolio following separation from the American Medical Systems (now Boston Scientific Corporation) Men’s Health business: confirmed.
• Instrumental in the establishment of monthly CAPA update meetings to ensure owners receive CAPA Mentor support, comply with procedures, and adhere to phase timelines.
• Tracked symptom evaluation and CAPA phase documentation, deadlines, and performance metrics to ensure proper functioning of the CAPA system.
• Actively participated in external and internal audits, including audit preparation activities and back room support.
• Utilized technical writing expertise to write new and update current Quality System procedures, work instructions, data capture forms, and document templates.
• Managed company-wide offsite records storage system; oversaw the accurate transfer of tracking information for >5000 containers to an offsite storage tracking database and streamlined shipment preparation processes.

Lake Elmo, Minnesota, US

• Worked closely with a team of Subject Matter Experts, Quality Engineers, and Project Managers to develop risk management processes incorporating “quantitative” methodologies and requirements per EN ISO 14971:2012.
• Gathered input from project teams and authored Quantitative Risk Management Process (QRMP) documentation, including policies, procedures, work instructions, and data capture forms.
• Facilitated technical reviews of documents and managed document revisions and change orders in the Agile Product Lifecycle Management (PLM) system.

US

• Used scientific background and critical thinking skills to analyze information including client product literature (IFUs, marketing materials, Risk Management documentation), clinical data, and FDA databases (MAUDE.
• Wrote or significantly contributed to the writing of 10+ Clinical Evaluation Reports to secure EU regulatory approval of medical devices including orthopedic implants and instruments.

Minneapolis And St. Paul, Minnesota, US

• Led studies using induced pluripotent stem cells as derivatives of insulin-producing beta cell precursors for treatment of type 1 diabetes.
• Managed day-to-day operations of the laboratory; oversaw projects and technical staff, managed schedules, placed orders and interacted with sales representatives.
• Successfully designed and instituted use of data analysis templates and experimental plan reporting systems to ensure accuracy and clarity.
• Authored Institutional Animal Care and Use (IACUC) and Institutional Biosafety Committee (IBC) protocols.

Minneapolis And St. Paul, Minnesota, US

• Led implementation of a quality assurance program in order to ensure maintenance of good laboratory practices (GLP) in pre-clinical trial activities.
• Used quality management software to review and approve draft documents, manage staff training records, record and review non-conforming work, and determine corrective/preventative actions.
• Streamlined sample log forms and developed SOPs to ensure samples were processed and documented in a consistent manner.
• Ensured assays adhered to guidelines and schedules listed in pre-clinical study protocols. Worked with Director to further analyze results and prepare reports for communication to core leaders and University-wide.

Minneapolis And St. Paul, Minnesota, US

• Interacted regularly with the SDI Chief Financial Officer and Department of Surgery accountants to manage budgets for grant and philanthropic funded research projects totaling greater than $1 million.
• Managed laboratory supply needs through use of University’s PeopleSoft Enterprise Financial System (EFS).
• Collaborated with national companies on the development of study objectives and scope of research plans for three National Institutes of Health (NIH) Small Business Innovation Research Grants (SBIR).
• Worked with Department accountants in the setup of a fee for service organization. Used knowledge of quality control assay technical and time requirements in determining costs and projecting core budgets.
• Reviewed porcine and human islet quality control activities to ensure accuracy of results and compliance with SOPs.

Minneapolis And St. Paul, Minnesota, US

• Designed and conducted a research project focused on elucidation of the mechanism of action of small proteins involved in the retroviral life cycle utilizing a combination of biochemical and biophysical techniques.
• Gained extensive experience in purification of fusion-tagged and untagged small and large proteins synthesized via bacterial protein overexpression. Routinely utilized plasmid construction techniques including plasmid.
• Independently conceived and wrote a NIH Ruth L. Kirschstein National Research Service Award (NRSA) grant proposal; awarded grant in July 2004. Also assisted advisor in research plan development and writing of two NIH.
• Communicated research findings through co-authoring three manuscripts published in peer-reviewed journals including a first author manuscript and presenting at national and international meetings. Selected for an oral.
• Managed laboratory for six months following advisor’s move to new institution; included role as authorized approver of purchase orders and coordinator of group laboratory meetings.

Chestnut Hill, MA, US

Research Adviser: Larry W. McLaughlin, Ph.D. Thesis: Synthesis of Multi-Arm Metal-Centered DNA Conjugates and Their Use Toward the Assembly of Supramolecular DNA-Metal LatticesSynthesized heterocyclic ligands and metal complexes for use towards the construction of higher-ordered DNA-metal complex structures. Developed techniques for synthesizing DNA-metal.

Bachelor Of Science, Chemical Biology

Ph.D, Chemistry