Medical Devices Engineer

2 days ago


Bellingham, Massachusetts, United States KARL STORZ Endoscopy - America Full time
Unlock Your Potential as a Sterile Single Use Sterilization Engineer

At KARL STORZ Endoscopy - America, we're seeking a highly skilled and motivated Sterile Single Use Sterilization Engineer to join our team. As a key member of our engineering department, you'll play a critical role in ensuring our medical devices meet the highest regulatory standards, directly contributing to our core business strategy.

Key Responsibilities:
  • Develop and implement sterilization processes for Single Sterile Use (SSU) medical devices
  • Collaborate with cross-functional teams on product designs and process improvements
  • Manage relationships with sterilization providers and ensure rigorous release testing protocols
  • Represent KSUS in communications with regulatory bodies, ensuring all products meet federal standards
  • Implement and maintain internal quality systems in alignment with FDA Quality System Regulation, ISO 13485, and ISO 9001
Requirements:
  • Bachelor's degree in Toxicology, Biology, Chemistry, Chemical Engineering, or Material Science
  • In-depth knowledge of CFR regulations pertaining to medical device sterilization and ISO 13485 standards
  • Proficiency in MS Office, especially Excel; strong data analytic skills
  • Strong analytical and problem-solving skills, with experience in Lean Manufacturing, Six Sigma, and Continuous Improvement principles
  • Proven project management capabilities
About Us:

KARL STORZ Endoscopy - America is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike. With a 9000 employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support.



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