Production Specialist

Production Specialist

We are seeking a detail-oriented and safety-conscious Production Specialist to support the reconfiguration of mobile devices into dedicated PDMs (Personal Diabetes Managers) as well as assembling our Starter and Controller kits. This role involves hands-on assembly, testing, inventory management, and collaboration across Quality, Engineering, and Supply Chain teams. This role plays a key part in executing manufacturing operations, with a strong focus on safety and quality standards to produce finished goods such as the Personal Diabetes Manager (PDM). All activities will be carried out in alignment with approved procedures and documentation specific to medical device production, ensuring the highest levels of patient safety and product integrity. The position also actively contributes to Continuous Improvement initiatives and Lean methodologies, helping to enhance operational workflows and drive performance across key metrics including safety, quality, efficiency, and cost. Cross-training opportunities may be available to support broader functional capabilities.

Production & Assembly: Safely reconfigure mobile devices into dedicated PDMs according to production schedules Operate test fixtures including USB interfaces, touchscreens, keyboards, and pneumatic RF-sealed enclosures Physically unbox, assemble, label, and transact light components and finished goods

Quality & Compliance: Identify and report discrepancies in quality, safety, or process execution Collaborate with Quality, Engineering, and management to resolve issues Ensure adherence to current SOPs and regulatory standards (FDA 21CFR, ISO 13485, cGMP) Maintain a clean and compliant work environment suitable for medical device production Inventory & Kitting: Perform data entry, cycle counts, and inventory reconciliation Organize components into kits per instructions; inspect for quality and accuracy Maintain accurate inventory records and support stocking levels on the floor Continuous Improvement & Teamwork: 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

Required Skills and Competencies: Ability to distinguish red, green, and blue colors on handheld devices Proficient in English; able to follow verbal and written instructions Strong organizational skills and attention to detail Comfortable working with light assemblies and basic mechanical tasks

Preferred Education and Experience: High School Diploma / GED Experience in regulated manufacturing environments preferred

Physical Requirements: Must be able to lift and transfer up to 50 lbs. Stand for extended periods. Perform repetitive tasks. Must be able to safely operate electric and manual pallet jacks. Ability to follow electronic training instructions and manual demonstrations.