Assembler (Contractor- 6 Months with a possibility of Extension)

About the Role

This role will facilitate material needs, build, assemble, test, and cable assemblies for various subsystems of the catheter platform. It offers a tremendous opportunity to work on creative and innovative problem-solving while interfacing with Manufacturing engineers. The ideal candidate should be experienced in typical catheter manufacturing processes, including hotbox work, braiding, adhesive bonding, soldering, and laminating, and comfortable working with minimal supervision. This is a hands-on position assembling products following written instructions, reporting to the Production Manager.

Responsibilities

• Manufacture clinical units, including preparation, cleaning, coating, catheter preparation, device inspection, and packaging.
• Organize, assemble materials, and product shipments to support commercial and development programs.
• Inspect and test clinical units.
• Maintain work area cleanliness and compliance with safety, fire, and hazmat guidelines.
• Execute work in compliance with FDA and ISO guidelines for medical device development and manufacture.
• Maintain compliance with all document and procedure training requirements.
• Assemble products in accordance with standard work instructions, MPIs, and prints.
• Test functional performance of completed assemblies using established procedures and test protocols.
• Facilitate preparation work such as line clearance, cycle counting, and verifying equipment maintenance and calibration dates.
• Ensure accuracy of documentation, initiate basic material requests, and report quality or efficiency issues.
• Maintain accuracy of material transactions and cycle count raw material, sub-assemblies, and work-in-progress material.
• Accurately determine and report shortages.
• Follow all corporate, regulatory, safety, and production policies and procedures.
• Maintain a clean and safe work environment.
• Perform other duties and tasks as assigned.

Requirements

• Mechanical aptitude.
• Ability to work with small, meticulous materials under a microscope.
• Minimum of 2 years of experience.
• High School diploma or higher.
• Adept at working in group settings or individually with minimal supervision.
• Good interpersonal communication skills.
• Positive attitude and flexibility to changes in work assignment.
• Ability to exercise sound independent judgment with minimal supervision.
• Basic computer skills (Outlook, Microsoft Word/Excel) to maintain accurate records and files.
• Good written and verbal communication.
• Ability to work overtime as required.

Physical Demands

• Using personal protective equipment to perform work when required.
• Lifting and moving products up to 25 lbs. in weight.
• Frequent sitting, standing, bending, reaching above the head, kneeling, crouching, walking, and/or stretching during the duration of a shift.
• Pushing and pulling product up to 25 lbs. in weight during the duration of a shift.
• Manual dexterity of both hands and wrists.

Schedule

This is a full-time position. Days and hours of work are Monday through Friday, with work hours varying between 4:00 AM (Day) and 2:00 PM (Swing). Occasional evening and weekend work may be required as job duties demand.

Pay

Salary Range: $30/hr - $33/hr. The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location, and market conditions.

Additional Requirements

• Employment is contingent upon successfully completing a pre-employment background check and/or drug screen.
• Certain roles require work in environments with radiation sources (e.g., x-ray equipment). Employees will be issued a personal dosimetry badge to monitor occupational exposure and are required to wear it in accordance with company policy and regulatory standards.