Medical Sewer

Medical Sewer / Assembly Operator

This role supports daily operations by performing precise sewing and final assembly of medical devices, including valves and related components, within a cleanroom environment. As a key member of the Operations team, you contribute directly to upcoming clinical milestones by building products that support clinical trials and research and development activities. This position offers significant opportunity for growth as you expand your skills across multiple assembly processes and production-related systems.

• Perform final assembly of medical devices, including sewing and assembling valves and related components according to established procedures and specifications.
• Support operations builds of valves to supply clinical trials and research and development builds, ensuring products meet quality and documentation requirements.
• Read, comprehend, and follow detailed written procedures and work instructions, and accurately follow verbal instructions from supervisors or leads.
• Utilize microscopes and other specialized equipment to handle and assemble small components and parts with high precision and attention to detail.
• Follow good manufacturing practices (GMPs) and cleanroom protocols at all times, including proper gowning procedures when entering and exiting clean rooms.
• Use electronic data collection systems and computer software to record production data, complete documentation, and maintain accurate, up-to-date job records.
• Prioritize work effectively by determining the sequencing and timing of tasks based on precedence, importance, and production requirements.
• Ensure that all relevant job documentation for operations and functions remains accurate, complete, and current.
• Help maintain cleanroom standards by following appropriate cleaning procedures and contributing to a safe, organized, and compliant work area.
• Work independently with minimal supervision while staying focused, productive, and aligned with production goals.
• Collaborate effectively with team members, demonstrating strong interpersonal skills and a willingness to assist others to meet shared objectives.
• Adapt to an evolving environment and take on a broad range of responsibilities as production and clinical needs change.
• Maintain an acute awareness of finished product quality and promptly report any issues, nonconformances, or process deviations.

• Experience in medical device manufacturing, including hands-on assembly work.
• 3–5 years of experience working in a cleanroom environment with production-related systems and procedures, preferably involving catheters or similar devices.
• Ability to read, comprehend, and follow written procedures and work instructions, as well as understand and follow verbal directions.
• Ability to be cross-trained, certified, and perform all required functions of the position.
• Knowledge of and ability to correctly perform basic math functions such as addition, subtraction, multiplication, and division.
• Knowledge of and ability to follow good manufacturing practices (GMPs).
• Understanding of and ability to utilize electronic data collection systems and computer software packages for production and documentation.
• Ability to prioritize work by sequencing tasks and managing time based on precedence and importance.
• Ability to handle and maneuver small components and parts with precision.
• Strong attention to detail and acute awareness of finished product quality.
• Ability to work independently and remain focused with minimal supervision.
• Ability to use microscopes for detailed assembly work.
• Ability to follow gowning procedures and adhere to cleanroom entry and exit requirements.
• Good hand dexterity and eye–hand coordination for fine sewing and assembly tasks.

• Experience with medical device sewing, medical assembly, and medical device assembly processes.
• Experience in working with valves, tissues, and catheter-related products is preferred.
• Comfort working with production-related systems, procedures, and documentation in a regulated environment.
• Strong interpersonal skills with the ability to work well with others in a team-oriented setting.
• Goal-oriented and driven mindset, approaching activities with a sense of urgency and ownership.
• Adaptability to an evolving environment with a broad range of responsibilities.
• Detail-oriented and quality-focused approach to all aspects of work.

You will join a mission-driven organization where your work directly supports critical clinical milestones and innovative medical solutions. The culture emphasizes collaboration, continuous learning, and cross-training, giving you the opportunity to broaden your skills and grow professionally. You will work in a structured, quality-focused environment that values precision, reliability, and personal accountability, while offering the chance to contribute meaningfully to patient-focused outcomes.

This position operates primarily in a controlled cleanroom…