Assembler, Manufacturing ​/ Production

Job Title:

Assembler I Job Description

• Perform electro-mechanical and clean room device assembly and packaging for medical devices in a regulated production environment.
• This role relies on strong manual assembly skills, meticulous attention to detail, and the ability to consistently deliver high-quality work while collaborating effectively within a cross-functional team.

• This is a 4/10 schedule, Monday through Thursday, 5am to 3:30pm
• They will be cross trained and candidates must be open to working on different lines/departments

• Perform electro-mechanical assembly and clean room device assembly according to established manufacturing procedures and engineering drawings.
• Package medical devices in compliance with applicable procedures, quality standards, and regulatory requirements.
• Support company goals, objectives, policies, procedures, Good Manufacturing Practices, and FDA regulations, including compliance with medical device quality standards.
• Follow and adhere to company Standard Operating Procedures (SOPs), departmental operating procedures (DOPs), quality assurance programs, and safety and environmental standards.
• Read, interpret, and follow manufacturing procedures, engineering drawings, and inspection procedures written in English, ensuring all requirements are met.
• Use basic hand tools, micrometers, calipers, and other equipment to assemble and verify components and products.
• Operate electrical and mechanical equipment and accurately interpret results to support production and quality requirements.
• Monitor work output for accuracy and completeness, demonstrating thoroughness and a strong focus on quality.
• Identify and report issues with tooling, materials, processes, or product quality and contribute to resolving them.
• Learn new equipment and processes quickly and demonstrate proficiency in their operation within the production environment.
• Transact product within the production system and complete required online training using computer-based programs.
• Communicate clearly and professionally with team members and other departments, both verbally and in writing, and demonstrate active listening.
• Establish, build, and maintain professional working relationships with staff, clients, and suppliers.
• Work effectively with minimal supervision while contributing positively to a cross-functional team.
• Practice and advocate good safety skills at all times, maintaining a clean and organized work area.

• At least 2 years of medical device assembly experience.
• Proficiency in electro-mechanical assembly and clean room production processes.
• Strong manual hand assembly skills with a high level of dexterity.
• Ability to read and interpret engineering drawings, manufacturing procedures, and inspection procedures in English.
• Experience working in a cleanroom and production environment.
• Ability to use basic hand tools, including micrometers, calipers, and similar measuring devices.
• Ability to operate electrical and mechanical equipment and accurately interpret results.
• Strong attention to detail with a focus on producing consistently high-quality work.
• Ability to detect and respond to issues with tooling, materials, processes, and quality.
• Ability to work well with others in a cross-functional team environment.
• Capability to work with minimal supervision while meeting deadlines.
• Effective interpersonal, verbal, and written communication skills.
• Ability to use a computer and various software programs to transact product and complete online training.

• Diploma or equivalent level of education.
• Familiarity with Good Manufacturing Practices and FDA regulations for medical devices.
• Experience adhering to Standard Operating Procedures (SOPs), departmental operating procedures (DOPs), and quality assurance programs.
• Demonstrated initiative and willingness to learn new equipment, processes, and systems.
• Ability to build and maintain professional working relationships with staff, clients, and suppliers.
• Strong sense of ownership for work quality and personal performance.
• Commitment to safety and environmental standards in a production setting.

• You will…