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Medical Device Sterilization Expert

2 months ago

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

Job Summary

KARL STORZ Endoscopy - America is seeking a highly skilled and experienced Senior Sterilization Process Engineer to lead our sterilization processes for Single Sterilization Use (SSU) medical devices.

Key Responsibilities

  • Oversee 510k/PMA design validation, verification testing, and documentation for SSU devices in the US market.
  • Manage relationships with sterilization providers and ensure rigorous release testing protocols.
  • Collaborate cross-functionally with engineering, regulatory, and manufacturing teams on new product designs and process improvements.
  • Represent KARL STORZ Endoscopy - America 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.

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 EN ISO 13485 standards.
  • Advanced proficiency in MS Office, particularly Excel for data analytics.
  • Strong analytical and problem-solving skills, with experience in Lean Manufacturing, Six Sigma, and Continuous Improvement principles.
  • Proven project management skills with the ability to manage multiple priorities effectively.

About Us

KARL STORZ Endoscopy - America is a leading manufacturer of endoscopic and medical imaging equipment. Our team of experts is dedicated to providing innovative solutions for the medical community. We are committed to delivering high-quality products and services that meet the highest standards of excellence.