Ryan Richelsen

Experience

1. Device Engineer

   Kymanox

   Oct 2021 — Present · Boston, MA, US

   Client-facing role that spans a variety of Technical Engineering, Quality, Project Management and Regulatory support for primarily Combination Products. Support to date has included- Assessing post-market surveillance data and literature searches for potential impact on product safety for Clinical Evaluation Reports (CERs) and Risk Management File (RMF) updates- Conducting RMF gap assessments against ISO 14971:2019 and suggesting strategies to resolve gaps- Conducting Design History File (DHF) gap assessments against FDA 21 CFR 820.30 Design Controls and proposing strategies for resolving gaps- Drafting Test Method Validation protocols and conducting Test Method Validation for container closure integrity (CCI) of a dual-chamber cartridge using vacuum decay- Supporting as Project Manager for devices in both feasibility and development stages of the product lifecycle by conducting reoccurring meetings with a cross-functional core team and 3rd party contract manufacturing organizations (CMOs)- Drafting Formative Study summary reports for Software as a Medical Device (SaMD)- Evaluating Summative Study results to categorize use errors to determine the most appropriate mitigation for use step error

Education

• University of Notre Dame

  Mechanical Engineering

  2015 — 2019