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Sterilization Engineer III

Fridley, Minnesota

Bewerben
Job ID 58182 Funktionsbereich Forschung & Entwicklung Vollzeit/Teilzeit Vollzeit Einstiegslevel Berufserfahrene

Sterilization Engineer III

[title]
Sterilization Engineer III
Permanent 

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.


About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

Position Summary

The Sterilization Engineer III at Medevio will play a key role in supporting global development projects and our clients across the full medical device lifecycle by planning and managing the sterilization activities for our products in collaboration with the external sterilization providers, including full sterilization validations and product adoptions. The Sterilization Engineer III will collaborate closely with internal cross-functional teams including Product Development, Operations, Quality, and Regulatory Affairs, but also external sterilization providers and our customers, ensuring sterilization strategies are aligned with project goals and regulatory requirements.

The Following Challenge Awaits You:

  • Lead sterilization activities for Medevio projects and clients worldwide, covering the entire medical device lifecycle.
  • Develop effective sterilization strategies based on customer, product and regulatory requirements with a high focus on EO sterilization.
  • Collaborate with internal stakeholders and customers to align on timelines and deliverables.
  • Assess sterilization needs for new products, changes, and projects and ensure the maintenance of the active sterilization validations as legally required
  • Coordinate with external partners such as sterilization service providers and test laboratories, including sample management, quotation processes, and critical review of protocols and reports.
  • Maintain up-to-date knowledge of global medical device regulations, particularly ISO 11135, and apply emerging standards and methodologies in sterilization, ensuring the implementation of regulatory requirements related to the sterilization of medical devices.
  • Other duties assigned as required.

Your Profile:

  • Bachelor’s degree in Engineering required (preferably Biomedical, Mechanical, Natural Sciences, Biotechnology or Chemistry), master’s degree in Engineering or related technical field helpful.
  • Minimum of 5 years of relevant work experience in medical device sterilization, especially on EO sterilization planning required; 1 year of relevant experience may be substituted for a graduate degree or 3 years for a doctorate.
  • Strong knowledge of applicable standards and regulations, including ISO 11135, ISO 13485, FDA regulations, and GMP.
  • Proven ability to manage and execute multiple projects simultaneously.
  • Capable of working both independently and collaboratively with minimal supervision.
  • Excellent problem-solving and interpersonal skills; able to communicate effectively across all organizational levels.
  • Documented sterilization training by a recognized third party or equivalent internal training by a subject-matter expert.
  • Ability to travel up to 25% of the time, both domestic and international.

Medevio is committed to providing competitive total compensation and benefits packages. The expected base salary hiring range for this position is between $100,000.00 and $120,000.00, based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity. This position is bonus eligible, with a target bonus of 10% of base salary depending upon company and individual performance. Our total compensation package also includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.

Curious? Apply now!

Heraeus is proud to be an employer that provides equal access to opportunities for all its employees. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected veteran status, age, or any other legally protected characteristic. A diverse and inclusive culture is at the heart of our Vision, Mission, and Values. We are dedicated to cultivating a workforce that reflects a broad spectrum of cultures, backgrounds, and perspectives.   

Any further questions?

If you need any assistance or have questions, please contact hrdirect-americas@heraeus.com or visit our website at jobs.heraeus.com.


ReqID: 58182
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