Production Specialist
About The Position
The Production Specialist supports the reconfiguration of mobile devices into Personal Diabetes Managers (PDMs) and the assembly of Starter and Controller kits. The role involves hands-on assembly, testing, inventory management, and collaboration with Quality, Engineering, and Supply Chain teams. It contributes to manufacturing operations for medical-device products, following approved procedures and documentation to uphold patient safety and product integrity. The position also participates in Continuous Improvement and Lean initiatives to improve operational workflows and performance in safety, quality, efficiency, and cost. Cross-training opportunities may be available.
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 21 CFR, 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 stocking levels on the floor.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
