Samantha Muncer

About Samantha Muncer

Senior Development Engineer with a demonstrated history of working in the medical device…

Experience

1. Senior Development Engineer

   Smith Nephew

   Oct 2022 — Present

   Functioned as a project manager for 5 tech files containing a total of 85 SKUs - managing 4 simultaneously containing a total of 72 SKUs - and acted as a product subject matter expert for Regulatory, Clinical and Medical Affairs, Biocompatibility, Technical Communications, and other departments as needed for EU-MDR Class IIB ENT and Sports Medicine Coblation controllers and wands, suture cartridges, and EU-MDR Class IIA suture passers; updated R&D and Quality documentation including Design Control documents, Verification/Validation, FMEAs, Risk Management files, and Instructions for Use in line with the General Safety and Performance Requirements specified within the EU-MDR legislation for all devices, frequently communicating, collaborating, and negotiating with up to 7+ different business units and colleagues both on contributor level and in management • Wrote protocols and acceptance criteria and conducted functional testing for controllers, wands, foot pedals, flow valves, suture passers, and suture cartridges; ensured all product testing data is developed to EU-MDR standards by performing V&V assessments against existing product specifications and standards to identify and correct any gaps • Provided R&D and Quality engineering support for correcting quality problems in released product, Regulatory re-submissions, NPD deliverables, and Product Support; established new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under the MDR legislation; collaborated with Regulatory Affairs on the preparation of Technical Files and other required supporting documentation for notified body audits; provided guidance to immediate team members • Improved multiple team processes to enable efficient use of time, for example creating a macro to populate DFMEAs to cut the process from taking a few weeks to one or two days and creation of a “Compliance Tool”

Education

• Penncrest High School

  High School

  2009 — 2013

• Penn State University

  Bachelor’s Degree, Biological Engineering

  2013 — 2017

Skills

• Matlab
• Engineering
• Microsoft Excel
• Microsoft Office
• Computer-Aided Design (Cad)
• Public Speaking
• Solidworks
• Microsoft Powerpoint
• Leadership
• Social Media
• Teamwork
• Geometric Dimensioning & Tolerancing
• Microsoft Word