Design Assurance Engineer IV

3 weeks ago

Charlton, United States KARL STORZ Endoscopy - America Full time

Are you a detail-oriented engineer passionate about compliance and technology? Join KARL STORZ as a Design Quality Assurance Engineer IV and play a crucial role in shaping the future of medical technology

 

What you'll be doing:


You will oversee global component planning, establish standards, and solve complex vendor-related issues while ensuring compliance with regulatory requirements.
Collaborate with other Engineering teams to analyze components, reduce costs, and set specifications.
Manage compliance with regulations like China RoHS and REACH, working closely with QA teams.
Facilitate end-of-life (EOL) projections and manage component replacements.
Maintain the global parts library and provide training on compliance standards.
Participate in product development teams to manage Design History Files and ensure adherence to FDA/QSR and ISO regulations.
Conduct internal audits and respond to corrective actions promptly.


 

What you'll need to be considered:


Bachelor’s degree in Mechanical, Electrical, or Software Engineering preferred.
Minimum of 10 years in component engineering, with 8+ years in a medical device environment.
Experience with reusable medical devices and familiarity with FDA Quality System Regulation (21 CFR Part 820) and ISO standards (13485, 9001).
Ability to evaluate electronic component data sheets in circuit designs is a plus.


 

Who we are:

KARL STORZ is an independent, family-owned supplier of advanced medical technology. For 80 years, we’ve pioneered the most groundbreaking innovations in endoscopy, surgical imaging, and OR integration to benefit patients and healthcare providers alike.  

 

Every day, we apply cutting-edge technology, precision engineering, and award-winning customer support to help healthcare facilities manage costs, streamline operations, and deliver exceptional patient outcomes. With facilities across the country and countless opportunities in the field, we attract a diverse and talented staff, motivated by the chance to make a lasting positive impact. At KARL STORZ, it’s not just about the tools we create —it’s about the lives we change, together. 

 

Apply Today to make an impact in the medical device industry

 

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