Medical Assembler

Medical Assembler

This role focuses on assembling implantable medical devices used to treat rotator cuff injuries, with a primary emphasis on tying precise knots in suture repair lines around very small anchors. You will work with both implantable sub-assemblies and molded plastic components to create complete cartridges and the apparatus used to implant sutures, ensuring each product meets strict quality and documentation standards.

Responsibilities

• Assemble implantable medical sub-assemblies (cartridges) that hold suture repair lines used to attach tendon to bone in rotator cuff repair procedures.
• Tie extremely small and precise knots in suture repair lines around anchors, using microscopes as needed to ensure accuracy and consistency.
• Perform secondary assembly operations by fitting and assembling molded plastic parts to form the shell of the cartridge and the device used to implant sutures.
• Handle and work with implantable medical products in accordance with established procedures and good documentation practices (GDP).
• Complete and maintain all required documentation on travelers and related production records accurately and legibly.
• Inspect small components and completed assemblies visually and under a microscope to verify quality and adherence to specifications.
• Follow cleanroom protocols and gowning requirements, including proper use of cleanroom personal protective equipment (PPE).
• Support packaging and inspection activities as needed to ensure finished medical devices meet quality and regulatory requirements.
• Maintain a high level of attention to detail to ensure the highest product quality throughout the assembly process.
• Collaborate with team members to learn and perform a variety of production tasks beyond knot tying as business needs require.

Essential Skills

• Minimum of 1 year of hands-on manual medical assembly experience, specifically involving manual assembly rather than machine-assisted processes.
• Demonstrated excellent hand dexterity and fine motor skills for tying very small knots and handling miniature components.
• Experience handling implantable medical products in a production or cleanroom environment.
• Proficiency in using microscopes to assist with assembly, inspection, and verification of very small parts.
• Strong attention to detail to ensure the highest quality of implantable medical devices.
• Ability to follow and complete production documentation, including travelers, in accordance with good documentation practices (GDP).
• Experience with cleanroom work practices and adherence to strict cleanliness and contamination control standards.
• Expereince in medical assembly, medical device assembly, or related medical device production environments.
• Ability to perform inspection and packaging tasks in a regulated medical device environment.

Additional Skills & Qualifications

• Experience working in a startup or small medical device manufacturing environment.
• Familiarity with general assembly processes, including handling molded plastic components.
• Comfort working with microscopes and other precision inspection tools for extended periods.
• Knowledge of basic quality and inspection practices within medical device manufacturing.
• Ability to adapt to learning multiple tasks and roles within a growing production team.

Why Work Here?

You will join a small, growing company where you can contribute directly to building and scaling a new medical device operation. The environment offers variety in daily tasks, allowing you to learn many different jobs rather than performing the same task every day. There is strong potential for rapid growth and advancement as the organization expands. The company supports flexibility in scheduling and provides opportunities to make up hours when unexpected situations arise.

The culture emphasizes community and connection, including informal events such as summer picnics and cookouts.

Work Environment

You will work in a cleanroom environment that requires strict adherence to cleanliness and contamination control procedures. Cleanroom personal protective equipment (PPE), including booties, hairnet, and safety glasses, must be worn at all times in designated areas. The role involves…