Medical Device Assembly Specialist — Lean Operations

Proclinical; Zug; Sur place; CHF 35 000 - 55 000; Plein temps

Résumé du poste

Proclinical is seeking a Production Specialist in Acton, MA to support the assembly and reconfiguration of mobile devices into Personal Diabetes Managers (PDMs) and to prepare Starter and Controller kits. The role emphasizes safety, quality, Lean initiatives, and cross-functional collaboration with Quality, Engineering, and Supply Chain teams.

Candidates should have a High School Diploma or GED, color vision, proficient English, strong organizational skills, and the ability to lift up to 50 lbs.

Qualifications

• High School Diploma or GED required.
• Experience in regulated manufacturing environments preferred.
• Must lift and transfer up to 50 lbs, stand for extended periods.
• Ability to distinguish colors on handheld devices.
• Proficient in English with ability to follow instructions.
• Strong organizational skills and attention to detail.
• Comfortable with light assemblies and basic mechanical tasks.
• Ability to operate pallet jacks.

Responsabilités

• 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.

Connaissances

Color vision

English proficiency

Attention to detail

Light assembly

Regulated manufacturing

Data entry

Teamwork

Pallet jack operation

Formation

High School Diploma or GED

Description du poste

Proclinical is seeking a Production Specialist in Acton, MA to support the assembly and reconfiguration of mobile devices into Personal Diabetes Managers (PDMs) and to prepare Starter and Controller kits. The role emphasizes safety, quality, Lean initiatives, and cross-functional collaboration with Quality, Engineering, and Supply Chain teams.

Candidates should have a High School Diploma or GED, color vision, proficient English, strong organizational skills, and the ability to lift up to 50 lbs.