Lauryn Dichting, Product Development Engineer
Ms. Dichting joined Secure BioMed Evaluations after graduating from Clemson University in 2016 with a degree in Bioengineering, a concentration in Biomaterials, and a minor in Psychology. Lauryn’s senior design capstone project involved the design and development of a novel arterial anastomosis device to decrease operating room time. As part of her training, Lauryn shadowed surgeons to identify unmet clinical needs, create solutions for those needs, and to materialize those solutions into functional medical devices. Immediately upon joining Secure BioMed Evaluations, Lauryn jumped in with both feet and began managing medical device design and development projects.
Sincebecoming a part of the SBME team, Lauryn has been vastly involved with the creation of design history and technical files, including Design Controls, Risk Management, and Verification and Validation Testing documentation. In addition, Lauryn has assisted with the development of regulatory submissions for product approval by both foreign and domestic agencies. Lauryn’s understanding of project management, Design History Files, and Technical Files ensures an efficient development path with compliant design documentation.
Lauryn’s primary areas of expertise include project management and technical support. Lauryn’s engineering background provides her with the skills needed to excel in creating and maintaining all aspects of Design History and Technical files as well as ensure all design and regulatory requirements are met. Lauryn leads design review meetings to guarantee appropriate milestones are completed and directs clients to the next phase of the product commercialization process in a timely and efficient manner.
- Perform technical activities to ensure all design control requirements are met.
- Translate new product clinical needs into design inputs and outputs.
- Create and maintain design history file documentation essential for the design and product development of new and existing products.
- Provide leadership in the qualification of new product transfer from Design Controls to Verification and Validation.
- Offer technical leadership for complex projects involving multiple technologies (electronics, software, etc.).
- Lead design review meetings to direct clients to the next phase of the product commercialization process and ensure phase deliverables are met.
- Manage project schedules to guarantee adherence to desired timelines and optimal time management for efficient product development.
- Oversee contract manufacturers to ensure the highest quality of work is performed.
Medical Device Exposure
- Electronic Medical Devices, Hydrogels, Orthopedic Implants, Wound Matrices, Surgical Gauze/Sponges, Stents.
Secure BioMed Evaluations
Product Development Engineer
Translate new product clinical needs into design inputs and outputs. Responsible for creating, developing, and maintaining device history documentation essential for the design and product development of new and existing products.Perform technical leadership activities to guarantee all design control and regulatory requirements are met. Lead design review meetings to ensure project is progressing in a timely manner and direct clients to the next phase of the product commercialization process. Assist in the development of regulatory submissions for product approval by both foreign and domestic agencies.
Clemson University Bioengineering Department
Senior Design Capstone
Gained exposure to principles of engineering design and applications to medical devices through materials selection, fabrication processes, performance standards, cost analysis, and design optimization. Applied bioengineering and design principles to solve clinically relevant design problem in a team-based environment. Worked to analyze and design a solution to a current need in the medical industry through voice of customer surveys, market analysis, IP assessment, FDA device classification consideration, production and manufacturing methods, creating and implementing a verification and validation plan, as well as regulatory and reimbursement strategies. Presented prototypes and updates to faculty jury through bi-weekly written and oral presentations.
NIH DeFINE Program
Participated in a six week “Design Fundamentals in Needs-Finding Experience” program funded by the NIH. Shadowed and observed surgeries in the OR in order to perform needs-finding research in the medical field. Interacted and networked with numerous doctors and hospital staff to find areas of improvement with various tools, equipment, and procedures. The program also partnered with the Clemson University Research Foundation to provide participants with skills in technology commercialization in relation to medical devices from design and development to market approval.
- Bachelor of Science Degree, Bioengineering with a Biomaterials Concentration, Clemson University
- Minor, Psychology, Clemson University
7828 Hickory Flat Highway, Suite 120, Woodstock, GA 30188