Medical Device Assembler II: Quality, Mentoring & ISO

Precision Optics Corporation; Gardner (MA); Híbrido; USD 55.000 - 76.000; Jornada completa

Descripción de la vacante

Precision Optics Corporation in Gardner, MA seeks a mid-level medical device assembler to build and inspect a range of devices, ensuring compliance with ISO 13485 and FDA guidelines. You will follow detailed work instructions, operate precision equipment, mentor junior staff, and collaborate with engineering and QA to maintain high quality.

You will use your analytical and problem-solving skills to troubleshoot issues, document results, and contribute to continuous improvement in a cleanroom

Formación

• 2–5 years of experience in medical device assembly or related manufacturing.
• Certified soldering to ISO standards and proper epoxy handling.
• Experience with ISO 13485 or FDA guidelines for quality systems.
• Ability to mentor entry-level assemblers and lead small teams.
• Strong attention to detail and careful documentation practices.

Responsabilidades

• Follow work instructions and assemble devices using precision equipment.
• Perform quality control checks and escalate issues to maintain quality.
• Troubleshoot basic assembly issues to minimize downtime.
• Mentor and train entry-level assemblers and support team collaboration.
• Collaborate with engineering and quality assurance teams on improvements.

Conocimientos

Analytical skills

Troubleshooting

Attention to detail

Communication skills

Leadership & mentoring

Adaptability

Educación

High School Diploma or equivalent

College degree preferred

Herramientas

Automated equipment

Testing devices

Measuring instruments

Descripción del empleo

Description

As a mid-level medical device assembler, you will leverage your experience and technical skills to assemble and inspect a variety of medical devices, ensuring they meet stringent quality standards and regulatory requirements. This position not only allows you to deepen your expertise in the medical device industry but also plays a crucial part in delivering safe and effective healthcare solutions.

Principal Responsibilities

• Following work instructions and technical documentation, utilizing your experience in assembly techniques, and operating specialized equipment with precision.
• Responsible for conducting thorough quality control checks, escalating assembly issues, to ensure productivity and product quality.
• Troubleshoots basic assembly issues
• Mentor and train entry-level assemblers, fostering a collaborative team environment.
• Collaborates with engineering and quality assurance teams.

Requirements

• Proficient in various assembly techniques and tools
• 2-5 years of experience in medical device assembly or a related manufacturing field is required. Familiarity with specific types of medical devices will be advantageous.
• Advanced Technical Skills: Proficiency in assembly techniques and the use of specialized tools, such as automated equipment, testing devices, or precise measuring instruments, is necessary. Certified soldering to ISO standards and correct handling, measuring and mixing of epoxies is a must.
• Quality Control Knowledge: Experience with quality assurance processes, inspections, and documentation practices to ensure compliance with industry standards and regulations (such as ISO 13485 or FDA guidelines).
• Problem-Solving Abilities: Analytical and troubleshooting skills to identify assembly issues would be extremely beneficial.
• Leadership and Mentoring: Ability to guide and mentor entry-level assemblers; experience leading small teams or training new staff would be beneficial.
• Attention to Detail: Enhanced attention to detail to ensure that assembled devices meet rigorous standards for safety and efficacy.
• Effective Communication Skills: Strong verbal and written communication skills for reporting issues, collaborating with team members.
• Basic Computer Proficiency: Comfortable using computer software for documentation and tracking production.
• Adaptability: A Willingness to learn new technologies and adapting to new manufacturing practices will be necessary.

Education Requirements

High School Diploma or equivalent required. A college degree in a relevant field preferred. Equivalent experience may also be accepted.

Supervisory Responsibility

No supervisory responsibility.

Working Conditions

This job operates in manufacturing laboratory environments including ISO class 7 cleanrooms.

Physical surroundings

This role routinely uses standard office equipment such as computers, phones, filing cabinets. PPE required when in controlled environment rooms.

Physical Effort

While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.

Travel

Limited, local travel may be required

Other Requirements

This position involves access to technology that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant’s capacity to serve in compliance with U.S. export controls .