Job Description: Electromechanical Assembler
Company:
Biomeme
Department:
Manufacturing / Production
Reports To:
Production Supervisor or Manufacturing Engineering Manager
FLSA Status:
Non-Exempt
Position Summary
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.
Key Responsibilities
Device Assembly & Production
- 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.
Testing, Calibration & Documentation
- 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.
Quality & Compliance
- 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.
Problem Solving & Collaboration
- 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.
Skills & Qualifications
Required
- 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.
Preferred
- Experience working under ISO 13485, FDA 21 CFR Part 820, or similar regulated manufacturing frameworks.
- Prior experience assembling laboratory, diagnostic, or handheld electronic devices.
Physical Requirements
- Ability to sit or stand for extended periods while performing assembly tasks.
- Ability to lift and move up to 30–40 lbs.
- Manual dexterity for handling small components, wiring, and precise assemblies.
- Use of microscopes or magnification equipment for fine-detail work as needed.
Work Environment
- Combination of assembly floor, electromechanical workstation, and controlled environments (cleanroom/ISO Class areas as needed).
- Work may involve strict gowning/PPE requirements and adherence to contamination-control protocols.
- Occasional overtime may be required based on production schedules.
