Electromechanical Assembler

Biomeme, Inc.•Philadelphia, PA

About The Position

The Electromechanical Assembler at Biomeme is responsible for assembling, wiring, testing, and troubleshooting electromechanical components and devices used in Biomeme’s molecular testing platforms. This role performs precise, documented assembly work in accordance with SOPs, engineering drawings, and quality system requirements. The ideal candidate has strong mechanical and electrical assembly skills, high attention to detail, and experience working in a regulated manufacturing environment.

Requirements

High school diploma or equivalent; technical training in electromechanical systems preferred.
Experience assembling electromechanical devices or instrumentation (diagnostic, medical, or biotech preferred).
Ability to read and interpret schematics, mechanical drawings, and SOPs.
Proficiency with hand tools, torque drivers, and precision measuring instruments.
Strong attention to detail, documentation accuracy, and quality mindset.
Ability to work in a controlled or cleanroom environment when required.

Nice To Haves

Experience working under ISO 13485, FDA 21 CFR Part 820, or similar regulated manufacturing frameworks.
Prior experience assembling laboratory, diagnostic, or handheld electronic devices.

Responsibilities

Assemble electromechanical components, subassemblies, and finished medical/diagnostic devices according to drawings, schematics, and work instructions.
Build housings, frames, sensor assemblies, PCBA integrations, and optical/mechanical components as required.
Follow established manufacturing processes, batch records, SOPs, and BOMs.
Conduct functional, electrical, and mechanical testing on subassemblies and completed units.
Perform continuity checks, mechanical alignment verification, and system-level diagnostics.
Record all work in device history records (DHRs) and ensure accurate, compliant documentation.
Support validation builds, pilot runs, and engineering change implementations.
Adhere to Biomeme’s Quality Management System (QMS) and Good Manufacturing Practices (GMP).
Execute in-process inspections and report deviations or nonconformances.
Maintain compliance with ISO 13485, FDA regulations, and cleanroom/controlled-environment protocols.
Identify issues during assembly and collaborate with engineering and quality teams to troubleshoot and resolve.
Provide feedback on work instructions and support continuous improvement initiatives.
Participate in training for new processes, equipment, and quality requirements.