Medical Sewer - I, II, Sr.

We are seeking individuals who wish to learn Medical Sewer skills to join our team in Maple Grove, MN on a contract-to-hire. 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.

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

Physical Requirements

• Ability to perform highly precise manual work comparable to fine sewing, embroidery, or micro-assembly of small biological tissue components under magnification.
• Excellent fine motor skills and hand-eye coordination required.
• Ability to stand or sit for extended periods of time, often for the majority of the work shift.
• Ability to perform repetitive hand and finger movements requiring high levels of dexterity and precision.
• Ability to lift and move materials up to 25 pounds (or another weight appropriate for your environment).
• Ability to maintain steady hand control for delicate work involving small components or biological materials.
• Ability to work under magnification, including frequent use of microscopes or magnifying equipment for extended periods.
• Ability to visually inspect small components or tissue structures with a high degree of accuracy.
• Ability to maintain sustained focus on detailed tasks in a production or laboratory environment.

Work Environment

• Work is performed in a cleanroom and/or controlled laboratory environment.
• Employees must adhere to strict gowning procedures, which may include wearing gowns, gloves, masks, hair covers, and shoe covers.
• Must be able to work comfortably in a temperature- and humidity-controlled environment.
• May require handling biological materials, including treated animal tissue, in accordance with established safety and regulatory protocols.
• Must follow cGMP, ISO, and company quality system procedures at all times.
• Ability to work in a highly regulated medical device manufacturing environment with strict documentation and process controls.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 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.
• Ability to work without visa sponsorship of any kind

Compensation

Target base salary range: $24 - $30 /hr. Final compensation will be based on experience and alignment with role requirements.  Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

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