Manufacturing Assembler

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 detail-oriented assembler for medical device manufacturing. You will perform kitting, assemble and test devices, and maintain strict GDP/cGMP documentation.

The role requires hands-on skills with tools, microscope work, and precise data entry into BRs, DHRs, and MRP systems; you will ensure quality through in-process inspection and validation activities.

Qualifications

• Experience performing kitting and component preparation
• Familiar with cGMP, GDP, and QA documentation
• Ability to document data into BRs, DHRs, and MRP systems
• 2–4 years in medical devices assembly

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)

Skills

Hand tools proficiency

Precision measurement

Documentation

GDP / cGMP knowledge

Data entry

Tools

Microscope

Measuring instruments

Process equipment

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