Production Specialist

Hands-On Role in Medical Device Production

Play a hands-on role in producing life-changing medical devices that help people manage diabetes every day. This position supports the assembly and reconfiguration of mobile devices into Personal Diabetes Managers (PDMs) and the preparation of Starter and Controller kits. The role contributes to Continuous Improvement initiatives and Lean methodologies, enhancing operational workflows and driving performance across safety, quality, efficiency, and cost metrics. Cross-training opportunities may be available to expand your skill set.

Primary 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.
• 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.
• Ensure compliance with SOPs and regulatory standards (FDA 21CFR, ISO 13485, cGMP).
• Perform data entry, cycle counts, and inventory reconciliation.
• Organize components into kits per instructions, inspecting for quality and accuracy.
• Maintain accurate inventory records and support stocking levels on the floor.
• Participate in Lean initiatives and cross-functional problem-solving.
• Work independently and collaboratively to troubleshoot and implement corrective actions.
• Contribute ideas to streamline operations and improve process efficiency.

Skills & Requirements

• Ability to distinguish red, green, and blue colors on handheld devices.
• Proficient in English, with the ability to follow verbal and written instructions.
• Strong organizational skills and attention to detail.
• Comfortable working with light assemblies and basic mechanical tasks.
• High School Diploma or GED required.
• Experience in regulated manufacturing environments preferred.
• Must be able to lift and transfer up to 50 lbs, stand for extended periods, and perform repetitive tasks.
• Ability to safely operate electric and manual pallet jacks.
• Capable of following electronic training instructions and manual demonstrations.