Sterilization Process Engineer

2 weeks ago

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

Job Title: Senior Sterilization Process Engineer

KARL STORZ Endoscopy - America is seeking a highly skilled and experienced Senior Sterilization Process Engineer to lead our sterilization processes for Single Sterile Use (SSU) medical devices. You will be instrumental in advancing our SSU products, ensuring they meet the highest regulatory standards and contribute to our core business strategy.

As a key member of our team, you will have the opportunity to lead critical projects that ensure the safety and efficacy of life-saving medical devices. We offer a collaborative environment where your expertise will be valued and your contributions will directly impact the success of our SSU product line.

Key Responsibilities:

  • Lead the validation and compliance of clean rooms and sterilization processes.
  • 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.
  • Stay informed on emerging technologies and regulations related to sterilization and SSU devices.
  • 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; 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 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 globally independent, family-operated MedTech company that prides itself on harnessing leading technologies, precise workmanship, and dedicated customer support to support the future of medical technology. We are setting new standards in precision and safety, from improving diagnosis to enhancing outcomes. We see beyond the limits of traditional medicine. Because it's not just about the tools we create. It's about the lives we change.

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