Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia. Help us build a team that will shape the future of TAVR.

We are seeking a highly motivated and experienced Sr. Sterilization Scientist to join our growing team in Maple Grove, Minnesota. As a member of the R&D team, you will play a key role in ensuring the sterility and safety of our medical devices through leadership in sterilization validation, research, and development activities.

Main Responsibilities:

• Lead and conduct sterilization validation studies for new and existing medical devices, ensuring compliance with regulatory requirements (FDA, ISO, etc.)
• Develop and implement sterilization protocols for various sterilization methods (e.g., Ethylene Oxide, Gamma Irradiation)
• Conduct research and development activities to improve sterilization processes and efficacy
• Analyze and interpret sterilization data to ensure product sterility and safety
• Participate in the development and maintenance of sterilization-related documentation (e.g., validation reports, SOPs)
• Stay up to date on the latest advancements in sterilization science and regulatory requirements
• Collaborate effectively with cross-functional teams (engineering, R&D, quality) to ensure successful product development and launch
• Provide technical expertise and guidance on sterilization-related matters
• May participate in audits and inspections related to sterilization processes

Qualifications:

• Bachelor's degree in Microbiology, Biology, Chemistry, or a related field
• Minimum of 5 years’ experience in sterilization validation and/or related field
• Strong understanding of sterilization principles and methodologies (e.g., Ethylene Oxide, Gamma Irradiation)
• Proven experience in conducting and leading sterilization validation studies
• Experience in the medical device industry; requires in-depth knowledge of relevant regulatory requirements (FDA 21 CFR Part 820, ISO 11135, ISO 13485)
• Excellent analytical and problem-solving skills
• Strong written and verbal communication skills
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office Suite and data analysis software

Preferred Qualifications:

• Master's degree in a relevant field
• Certified Industrial Sterilization Specialist (CISS) certification
• Previous involvement with the formulation of sterilization cycles would be a plus
• Experience with various sterilization methods

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.

Health and Wellness Offerings:

• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Stock Option Plan
• Paid Holidays & Vacation
• Employee Assistance Program
• Inclusive Team Environment