Anteris Technologies 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.

We are seeking an experienced Medical Sewer to join our team in Maple Grove, MN. In this role, you will play a critical function in the production of bovine tissue heart valves, ensuring the highest quality standards are met while maintaining strict adherence to safety and regulatory guidelines. This position offers an exciting opportunity to contribute to the development of life-saving medical devices and work in a dynamic and collaborative environment.

This position reports directly to our Global Head, Vice President of Manufacturing and may take direction from our Lead Medical Technician and Manufacturing Engineer as needed. This position offers an exciting opportunity to contribute to the development of life-saving medical devices and work in a dynamic and collaborative environment.

Main Responsibilities:

• Sewing Operations: Perform intricate hand sewing tasks on bovine tissue heart valves using specialized equipment and techniques to ensure precise and consistent results.
  • Use tools – needles, scissors, forceps, specialized tooling, microscope or magnified light – to perform assigned steps, in rotation, in the sewing assembly of heart valves
  • Review, follow and perform job functions in compliance with established procedures and adherence with SOPs
  • Handle chemicals and solutions for processing biological tissue
• Quality Assurance: Maintain strict quality control measures by inspecting and verifying the integrity of sewn components, ensuring compliance with industry standards and company specifications.
• Documentation: Complete and maintain accurate records of sewing activities, including batch records, quality control reports, and production logs.
• Collaboration: Work closely with cross-functional teams, including engineers, quality control specialists, and production staff, to troubleshoot issues and optimize sewing processes.
• Safety and Compliance: Follow all safety protocols and adhere to regulatory requirements, including FDA guidelines and ISO standards, to ensure a safe and compliant work environment.
• Training and Development: Assist in training and mentoring junior sewing staff to improve skills and maintain a high level of proficiency within the team.
• Continuous Improvement: Participate in process improvement initiatives to enhance efficiency, productivity, and product quality.
• Other incidental duties including general workspace housekeeping

Qualifications:

• High school diploma or equivalent; additional vocational or technical training in sewing is a plus.
• Minimum of 2 years’ experience in medical device assembly, preferably with experience in medical sewing.
• Proficiency in operating sewing machines and equipment, specifically including the ability to perform intricate and delicate sewing tasks.
• Strong attention to detail and a commitment to maintaining the highest quality standards.
• Knowledge of FDA regulations and ISO standards related to medical device manufacturing is highly desirable.
• Excellent communication and teamwork skills.
• Ability to work independently and in a team-based environment.
• Strong problem-solving and troubleshooting skills.
• Ability to work the following shift: 5a – 1p.

Our Health and Wellness Offerings:

• Medical, Dental & Vision Offerings
• 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
• Paid Vacation
• Employee Assistance Program
• Inclusive Team Environment

Note: We may require proof of COVID-19 vaccination to comply with the state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.