Medical Sewer - Contract

Anteris Tech • Maple Grove, MN

21h

About The Position

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We sought to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve. We are seeking individuals who wish to learn Medical Sewer skills to join our team in Maple Grove, MN on a contract or temp-to-hire basis. 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 reports directly to our Production Supervisor and may take direction from Manufacturing Engineers as needed. The Medical Sewer role offers an exciting opportunity to contribute to the development of life-saving medical devices and work in a dynamic and collaborative environment. At Anteris® Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Requirements

• High school diploma or equivalent; additional vocational or technical training in sewing is a plus.
• Minimum of 2 years’ experience in medical device assembly preferred. Experience in medical sewing is a plus.
• Proficiency in performing intricate and delicate hand-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.

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

Benefits

• 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.
• The chance to be part of a growing company that values its employees.

What This Job Offers

• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 101-250 employees