Sterility Assurance Engineer

3 days ago

Bellingham MA, United States KARL STORZ Endoscopy - America Full time

Are you a dynamic and experienced engineer passionate about advancing sterilization processes for Single Sterile Use (SSU) medical devices?

 

Join KARL STORZ as a Sterile Single Use Sterilization Engineer and play a critical role in ensuring our products meet the highest regulatory standards, directly contributing to our core business strategy.

 

What's in it for me?

  • Impactful Work : Play a crucial role in the development of life-saving medical devices, ensuring their safety and efficacy in the healthcare market.

  • Career Growth : Work in a dynamic environment with opportunities for professional development, including exposure to cutting-edge sterilization technologies and regulatory practices.

  • Collaborative Culture : Join a team that values collaboration across departments, allowing you to learn from and share knowledge with experts in engineering, regulatory affairs, and manufacturing.

  • Innovative Environment : Be part of a family-operated company that prioritizes innovation and long-term vision over short-term gains, providing a stable and forward-thinking workplace.

  • Professional Development : Access to training and development opportunities to enhance your skills in Lean Manufacturing, Six Sigma, and Continuous Improvement principles.

  • Work-Life Balance : Enjoy a supportive work culture that recognizes the importance of work-life balance, allowing you to thrive both professionally and personally.

  • Global Influence : Contribute to a company with a global reach, impacting healthcare standards and practices on an international scale.

 

What you’ll be doing:

  • Lead the validation and compliance of clean rooms and sterilization processes (experience with ethylene oxide preferred).
  • Oversee 510k/PMA design validation, verification testing, and documentation for SSU devices.
  • Manage relationships with sterilization providers and ensure rigorous release testing protocols.
  • Collaborate with cross-functional teams on product designs and process improvements.
  • Stay updated on sterilization technologies and regulations related to SSU devices.
  • Represent KSUS in communications with regulatory bodies such as the FDA, ensuring all products meet federal standards.
  • Implement and maintain internal quality systems in alignment with FDA Quality System Regulation, ISO 13485, and ISO 9001.

What you need to be considered for the role:

  • Bachelor’s degree in Toxicology, Biology, Chemistry, Chemical Engineering, or Material Science; an advanced degree is preferred.
  • A minimum of 5 years of experience in various sterilization techniques, with a strong background in bringing SSU devices to market in the US.
  • 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; ability to manage multiple priorities effectively.

 

Who we are:

KARL STORZ 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. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes. It 's not just about the tools we create—it’s about the lives we change, together. 

 

#LI-BL1

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