Production Specialist

Job Description

Job Description

Job Title: Production Specialist
Location: Acton Massachusetts 01720
Shift: 2nd Shift

Job Description:
Position Overview:
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.

Responsibilities:
=' 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.