Production Specialist

LanceSoft•Acton, MA

2d•Onsite

About The Position

The Production Specialist supports the reconfiguration of mobile devices into dedicated Personal Diabetes Managers (PDMs) and assembles Starter and Controller kits. The role involves hands-on assembly and testing, inventory management, and collaboration with Quality, Engineering, and Supply Chain teams. It contributes to manufacturing operations focused on safety and quality while producing finished medical-device goods in accordance with approved procedures and documentation to protect patient safety and product integrity. The position also contributes to Continuous Improvement initiatives and Lean methodologies to improve workflows and performance across safety, quality, efficiency, and cost metrics. Cross-training opportunities may be available to support broader functional capabilities.

Requirements

Ability to distinguish red, green, and blue colors on handheld devices.
Proficiency in English and ability to follow verbal and written instructions.
Strong organizational skills and attention to detail.
Comfort working with light assemblies and basic mechanical tasks.
Ability to lift and transfer up to 50 lbs.
Ability to stand for extended periods and perform repetitive tasks.
Ability to safely operate electric and manual pallet jacks.
Ability to follow electronic training instructions and manual demonstrations.

Nice To Haves

High school diploma or GED.
Experience in regulated manufacturing environments.

Responsibilities

Safely reconfigure mobile devices into dedicated PDMs according to production schedules.
Operate test fixtures, including USB interfaces, touchscreens, keyboards, and pneumatic RF-sealed enclosures.
Unbox, assemble, label, and transact light components and finished goods.
Identify and report discrepancies in quality, safety, or process execution.
Collaborate with Quality, Engineering, and management to resolve issues.
Follow current SOPs and regulatory standards, including FDA 21CFR, ISO 13485, and cGMP.
Maintain a clean and compliant work environment suitable for medical-device production.
Perform data entry, cycle counts, and inventory reconciliation.
Organize components into kits according to instructions and inspect them for quality and accuracy.
Maintain accurate inventory records and support floor stocking levels.
Participate in Lean initiatives and cross-functional problem-solving.
Work independently and collaboratively in small teams to troubleshoot and implement corrective actions.
Support process efficiency and contribute ideas to streamline operations.