Manufacturing Technician

Groe Advisors LLC; Burlington (MA); On-site; USD 52,000 - 78,000; Full time

Job summary

Groe Advisors LLC in Burlington, MA is seeking a meticulous medical device assembler to join the operations team. You will perform kitting, assembly, testing, labeling, and documentation in a cGMP environment.

The role requires 2–4 years hands-on experience in electromechanical and optomechanical assembly, ability to work under a microscope, and strict adherence to BRs, DHRs, GDP, and SOPs. Proficiency with hand tools and precision measurement instruments is expected.

Qualifications

• Follow, execute, and adhere to documentation in accordance with cGMP, QMS, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), batch records (BRs), device history records (DHRs), and engineering batches.
• 2 to 4 years of hands‑on experience in medical devices, technical assembly, and both electromechanical and optomechanical environments.

Responsibilities

• Perform kitting operations (measure out components or raw materials).
• Ability to perform activities under a microscope.
• Prepare components and build device assemblies.
• Perform packaging and labeling operations.
• Proficiency with hand tools, precision measurement instruments, and data input into MRPs, BRs, and DHRs.
• Organize and clean work areas; validate and qualify activities (IQ/OQ/PQ/PV).

Job description

You will be responsible for the following:

• Perform kitting operations (measure out components or raw materials)
• Ability to perform activities under a microscope
• Prepare components and build device assemblies
• Perform packaging and labeling operations
• Proficiency with hand tools, precision measurement instruments, and
• Perform documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)
• Perform all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality management requirements.
• Additional tasks as required

RESPONSIBILITIES:

• ? Follow, execute, and adhere to documentation in accordance with cGMP, QMS, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), batch records (BRs), device history records (DHRs), and engineering batches.
• ? Perform basic calculations and data entry
• ? Ability to assemble, disassemble, and clean process equipment
• ? Process and assemble components in accordance with documented specifications and procedures
• ? Perform mechanical, optical, and system assembly, and conduct thorough testing
• ? Perform packaging and labeling operations
• ? Perform in-process inspection of assemblies and finished products in accordance with specification criteria
• ? Perform treatment card programming
• ? Organize and clean the work areas
• ? Ability to perform validation and qualification activities (IQ/OQ/PQ/PV)

WORK EXPERIENCE:

• ? 2 to 4 years of hands‑on experience in medical devices, technical assembly, and both electromechanical and optomechanical environments