Peyton Schroeder Email & Phone Number

Indianapolis, In, Us

Mentor, Oh, Us

Providing on-site Quality Engineering expertise for both the Indianapolis Certified Pre-Owned (CPO) business and the Distribution Center (DC.) Implementing Good Documentation Practices (GDP) and a Nonconformance program to assist the CPO site with preparing for eventual certification. Supporting CPO compliance activities such as evaluating existing in-process/final checklists and completing quality deliverables for New Service Capabilities Developments project. Collaborating with Quality and Manufacturing Engineering team members from OEM manufacturing sites when introducing new CPO capital equipment. Reporting and evaluating trends in quality metrics to support current and future operations decisions for surgical tables, automated endoscope reprocessers, sterilizers, washers, and surgical light assemblies. Processing nonconformances, complaints, and CAPAs. Managing DC processes including COC/COM generation and product containment activities. Participating in Kaizen events and 8-Step Problem Solving. Developing work instructions for standard work procedures. Serving as Indianapolis Document Control Coordinator and Training Coordinator. Ensuring adherence by all employees to any updated policies and procedures by sending out new trainings on a regular cadence and updating the training matrix. Conducting internal audits at other STERIS sites on an annual basis.

San Diego, Ca, Us

Supported the Global Implant Systems (GIS) Quality Engineering team while working cross-functionally to develop innovative spine solutions. Contributed to multiple New Product Development projects as a Quality Engineering lead while collaborating cross-functionally with NuVasive and Globus teams. Streamlined the Inspection Request process by producing a new all-inclusive module in the EtQ Reliance Quality Management System and served as a SME to train employees to their responsibilities within Quality, Development, Manufacturing, and Labeling. Implemented FDA Unique Device Identifier (UDI) requirements across all NuVasive instruments and implants by updating Quality Inspection Records in SAP. Ensured adherence to design controls by serving as a Quality Engineering lead on multiple projects while creating and reviewing documentation for implants and instruments. Owned the Risk Management file and risk analysis tasks to promote mitigation of risks for assigned projects. Utilized GD&T proficiency to review engineering drawings and guide generation of inspection methods. Investigated non-conformances identified at incoming inspection via Non-Conformance Reports (NCRs) and developed solutions with vendors to resolve non-conformances and mitigate future reoccurrences through Supplier Corrective Action Requests (SCARs). Advised project teams on sterilization validation requirements for internal and external suppliers.

Minneapolis, Mn, Us

Produced a preliminary version of a non-product tool validation BOM to organize Non Product Tool Validation (NPTV) reports related to ventilators in the Quality Management System (Agile). Reviewed technical documents written by cross-functional teams related to CAPAs and NPTV. Served as the independent quality reviewer for a project team. Referenced technical standards (including ISO 13485 and ISO 14971) and internal Medtronic risk management methods when reviewing documents within the Respiratory Interventions operating unit. Investigated trends in complaint data to produce signal evaluations and presented results to company on a monthly basis. Provided backroom support during FY23 internal audit as QA Reviewer. Provided mentorship to incoming/current Summer 2022 interns after being selected to participate in the Intern Ambassadorship Program. Provided ongoing support to interns and assisted with reviewing their final presentations.

Minneapolis, Mn, Us

Created an index for organizing ventilation Issue Impact Assessments (IIAs) arising in the field. Learned about risk management techniques pertaining to technologies within Respiratory Interventions. Developed hazards and correlated harms associated with new humidifier design via Design Failure Modes and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Participated in internship enrichment activities, including certificate programs from Harvard University.

Lexington, Kentucky, Us

Advised on-campus innovators on FDA medical device regulatory processes for various new technologies. Presented complex information to innovators in a clear, easy-to-understand format and provided recommendations as to device category under FDA and suggested product testing paths. Completed various other tasks to support the overall mission and business needs of the OTC. Assisted startup Cellie Coping Company with the process of creating a digital marketplace to be utilized as a channel for marketing and selling their cancer coping kits.

Louisville, Ky, Us

Designed automated tip change assembly system for use in BioAssemblyBots (3D bioprinters) with a variety of tip sizes. Coded Arduino and used a data acquisition system with a custom-made setup involving a linear potentiometer to test positioning accuracy of the movement of the tip change assembly system. Used mechanical and electrical tools to create iterative prototypes of new design ideas. Created custom components in CAD using the plastic and sheet metal part environments for the brackets and optical flags on the 3-axis gantry system of the tip change assembly. Used the assembly environment in CAD to ensure that all parts fit together with proper tolerancing while designing for cost-effective manufacturing. Programmed optical flags and sensors in the context of the full assembly to ensure that the carriage on the gantry system would not malfunction and cause a collision.

Promoted green practices across the company. Digitized quality criteria and production files for injection-molded plastic parts to promote efficiency by allowing for global access while reducing paper waste. Restructured printer system to eliminate waste and reduce annual printing costs by 45%. Assisted suppliers and customers to resolve issues related to part quality. Inspected parts for quality defects based on use of measurement equipment and visual inspection according to documented quality criteria. Wrote work instructions for quality control processes in a format understandable to both upper management and hourly employees on the manufacturing floor.

Lexington, Ky, Us

Mentored a group of high school women interested in engineering during a week-long camp. Assisted professors from all engineering departments with executing professional development activities for participants.

Raritan, Nj, Us

Participated on CONTOUR Curved Cutter Stapler surgical device team in New Product Development for the endomechanical group and completed both design and quality assurance tasks. Prepared animal tissue for testing and used complex laboratory equipment to conduct research on porcine colon tissue to test product claims such as amount of tissue leakage. Performed measurement system analysis (MSA) via Gage R&Rs to demonstrate validity of test methods used to prove product claims. Learned to use Instron and other machines to conduct tensile tests on specimens. Analyzed laboratory data and wrote professional engineering studies while following all company standards and adhering to FDA medical device regulations. Assisted other co-ops with their projects by serving as an operator for Gage R&R’s and participating in tissue testing for various robotic, energy, and endomechanical surgical devices in all stages of product development.

Parsippany, Nj, Us

Prototyped new structures for refrigerators by utilizing power tools and equipment such as milling machines and lathes to machine components. Designed parts in CAD for 3D printing purposes. Learned programming, circuits, and soldering while on the job. Conducted internal taste testing for various beverages that had undergone certain confidential processes by using a triangle test with proper statistical data analysis. Pursued in-depth research of patent literature and journals within the refrigeration field to ensure that innovations would not put the company at risk for legal issues. Managed selection, purchasing and systemic organization of new lab equipment for the unfinished refrigeration lab including hand tools, small electrical components, and basic fasteners. Spoke at monthly presentations to upper executives at the company on engineering topics such as Six Sigma, design for manufacturing (DFM), and house of quality in formal sessions.

Summer employment throughout high school. Worked on data entry, troubleshooting and assembling hardware, configuring databases, adding and organizing users on server, locating software, etc.

Bachelor Of Science - Bs, Mechanical Engineering

High School Diploma