Austin Tielke

About Austin Tielke

I am a dedicated Engineer specializing in New Product Design & Development within the Medical Devices and Diagnostics Industry. With a robust background in Sustaining Engineering, Systems Engineering, and Quality Engineering, I bring a wealth of experience in design inputs/outputs, verification and validation, usability evaluations, requirements management, risk management, testing & test method validation, quality documentation, and regulatory submissions.My professional journey has equipped me with a diverse skill set, including Agile/Scrum Methodology, Danaher Business System Tools, GD & T, Tolerance Analysis, Measurement System Analysis, Six Sigma, Requirements Trace Matrix, Verification and Validation, and various software tools such as Atlassian Jira, Siemens Teamcenter, SolidWorks, Minitab, and MATLAB. I am proficient in FDA ISO 13485/14971 standards and have extensive experience with FMEAs, JAMA Connect, and other industry-specific technologies.Currently, I work in Design Assurance Quality Engineering at AtriCure, where I currently support the next generation system of cardiac ablation technology.Previously, I was a Senior Systems Engineer at Mammotome, a Danaher company, where I led the lifecycle of Class II medical device projects from launch through regulatory approval as each project\'s technical SME. My role involved driving system architecture, collaborating with cross-functional stakeholders, ensuring compliance with international medical device regulations, and organizing detailed human factors engineering studies for regulatory submissions. I also mentored junior engineers and managed SaaS requirements and traceability software as the organization\'s administrator.Additionally, I also worked at Tata Consultancy Services for Ethicon (J&J MedTech), a Johnson & Johnson company, where I managed risk assessments, design requirement workbooks, and test method validations for surgical instruments. My interdisciplinary approach and agile methodology have consistently led to successful project outcomes and improved team performance.My academic background includes research in biomechanics and system dynamics at Arizona State University, where I published scholarly articles and led research teams. I have also interned at Ulthera, Inc, focusing on fault analyses and electrical output auditing.I am passionate about advancing medical technology and improving patient outcomes through innovative engineering solutions. Let\'s connect and explore how we can collaborate to drive the future of medical devices and diagnostics.

Experience

1. Senior Design Assurance Quality Engineer

   AtriCure, Inc.

   May 2025 — Present · Mason, OH, US

   On time quality delivery of assigned PD team deliverables to support an IDE study and a PMA submission.• Utilize systems engineering experience to align project teams on next-generation energy delivery platforms between capital equipment and handpiece disposables.• Ensure assigned design control procedures are compliant with FDA, GMP, ISO, etc.• Optimize existing processes to maximize efficiency and continue to identify, plan and execute continuous improvement activities.• Drive continuous improvements through observation, measurement and root cause analysis/resolution.• Develop new processes which support speed, cost reductions and quality improvements.• Provide subject matter expertise for assigned processes to users as necessary.• Responsible for cross functional collaboration with R&D, manufacturing, marketing, regulatory and clinical functions.• Provide investigative support/leadership for process quality issues.• Work with PD teams to help with cascading requirements from VOC through requirements and controls.• Work with PD teams on timely use of Risk Management activities including supporting and leading FMEAs.• Serve as technical resource for problem investigations to guide root cause analysis and corrective actions.• Provided mentorship to junior level design assurance engineers in design control and product development.• Ensure commitment to functional excellence and the ability to execute positive changes.

Education

• Arizona State University

  Master of Science - MS, Biomedical Engineering

  2017 — 2018

• Ira A. Fulton Schools of Engineering at Arizona State University

  Bachelor of Science in Engineering (BSE), Biomedical Engineering

  2013 — 2017

• Barrett, The Honors College

  Honors

  2013 — 2017

Skills

• Matlab
• Statistics
• Teamwork
• R Studio
• Microsoft Office
• Comsol
• Cadence Allegro Physical Viewer
• Management
• Microsoft Word
• Team Leadership
• Java
• Arduino
• Vicon Motion Capture Systems
• Retail Sales
• Signal Processing
• Pspice
• Leadership
• Customer Service
• Data Analysis
• Research
• Orcad Capture Cis
• Microsoft Excel
• Solidworks
• Windows
• Microcontrollers
• Jmp
• Time Management
• Labview
• C++