Design Control Specialist

• Nov 2021 - Present

I am working as a Design Control Specialist within R&D where I support the development of new medical device products throughout the entire development phase from project initiation to design transfer, additionally I am also responsible for maintenance of existing documentation. My primary responsibilities are: Device Risk Management Usability Engineering DMR/DHF/Technical file documentation Design Verification and validation Design Control tasks related to CAPA’s Design Control tasks related to Change Requests Audit participation Experience working with ISO 13485, ISO 14971, MDD/MDR (EU Regulation 2017/745), FDA CFR 21 Show less

Test Engineer

• Jul 2019 - Oct 2021

I worked as part of the Change Team at Convatec Infusion Care at Osted, Denmark. Our responsibility was changes to existing products. These changes involve anything from change of packaging materials, to changes in the original design, to material changes or changes in production sites. My responsibility was to ensure that after the changes had been implemented that the products were in compliance with the original design specifications including mechanical properties and shelf life. • Design Verification for Product Development and Life-cycle Management • Design Control • Data Analysis • Scrum - User Requirement Specification for test equipment • Test Method Validation - Measurement System Analysis: Gage R&R, Six Sigma - Test Method development, Screening, Design of Experiments (DOE) Show less

Teacher's Assistant in Organic Chemisty, Technical University of Denmark

• Feb 2016 - Aug 2018

Bachelor of Engineering - Internship at Haldor Topsøe A/S

• Jan 2017 - Jun 2017

Project lead on a project focused on replacing conventional production methods with metal 3D-printing for specially selected spare parts. Responsibilities: - Project management - Qualitative data collection and processing - Focus interviews with stakeholders - Written and verbal reporting Project lead on a project focused on replacing conventional production methods with metal 3D-printing for specially selected spare parts. Responsibilities: - Project management - Qualitative data collection and processing - Focus interviews with stakeholders - Written and verbal reporting