Medical Sewer - I, II, Sr.

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.
• 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 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.