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Designer

On-site United States

Job Summary

Key Responsibilities

  • Perform intermediate level electro‑mechanical assembly of robotic system modules including joints, control modules, and cable harnesses using engineering documentation and established work instructions with minimal supervision.
  • Operate within a structured production line environment to meet daily build targets while maintaining compliance with ISO 13485, FDA QSR, and Good Documentation Practices (GDP).
  • Interpret and apply defined assembly procedures to correctly build, verify, and validate mechanical and electromechanical components across multiple product modules.
  • Conduct functional, electrical, and mechanical tests using calibrated tools, test fixtures, torque equipment, and multimeters.
  • Identify, and troubleshoot basic electrical and mechanical issues (e.g., miswiring, misalignment, sensor faults) and escalate complex or systemic issues to engineering.
  • Perform minor mechanical and electrical repairs to support production continuity, escalating complex issues to engineering.
  • Maintain compliance with ESD controls, clean manufacturing protocols, and contamination‑control standards appropriate for medical device manufacturing.
  • Accurately document production activities, test outcomes, and inspection data in MES, ERP/SAP, and electronic DHR systems following GDP.
  • Perform in‑process inspections and contribute to quality verifications to ensure adherence to workmanship and regulatory standards.
  • Assist in process updates by providing feedback on assembly sequences, documentation accuracy, and fixture/tool improvements.
  • Support manufacturing engineering on the line setup, fixture validation, new product introduction (NPI) builds, and continuous improvement initiatives.
  • Support training, knowledge‑sharing, and guidance for new or entry-level technicians
  • Prepare production lines by performing line clearance, verifying equipment maintenance and calibration status, and ensuring material readiness—which includes accurate material transactions, cycle counts of raw materials, sub‑assemblies, and WIP, as well as proactively identifying and reporting shortages or discrepancies to prevent build interruptions and support efficient production scheduling.
  • Maintain certification and demonstrate proficiency on at least three designated modules while meeting all safety, quality, and training requirements.

Key Responsibilities

Key Responsibilities

  • Perform intermediate level electro‑mechanical assembly of robotic system modules including joints, control modules, and cable harnesses using engineering documentation and established work instructions with minimal supervision.
  • Operate within a structured production line environment to meet daily build targets while maintaining compliance with ISO 13485, FDA QSR, and Good Documentation Practices (GDP).
  • Interpret and apply defined assembly procedures to correctly build, verify, and validate mechanical and electromechanical components across multiple product modules.
  • Conduct functional, electrical, and mechanical tests using calibrated tools, test fixtures, torque equipment, and multimeters.
  • Identify, and troubleshoot basic electrical and mechanical issues (e.g., miswiring, misalignment, sensor faults) and escalate complex or systemic issues to engineering.
  • Perform minor mechanical and electrical repairs to support production continuity, escalating complex issues to engineering.
  • Maintain compliance with ESD controls, clean manufacturing protocols, and contamination‑control standards appropriate for medical device manufacturing.
  • Accurately document production activities, test outcomes, and inspection data in MES, ERP/SAP, and electronic DHR systems following GDP.
  • Perform in‑process inspections and contribute to quality verifications to ensure adherence to workmanship and regulatory standards.
  • Assist in process updates by providing feedback on assembly sequences, documentation accuracy, and fixture/tool improvements.
  • Support manufacturing engineering on the line setup, fixture validation, new product introduction (NPI) builds, and continuous improvement initiatives.
  • Support training, knowledge‑sharing, and guidance for new or entry-level technicians
  • Prepare production lines by performing line clearance, verifying equipment maintenance and calibration status, and ensuring material readiness—which includes accurate material transactions, cycle counts of raw materials, sub‑assemblies, and WIP, as well as proactively identifying and reporting shortages or discrepancies to prevent build interruptions and support efficient production scheduling.
  • Maintain certification and demonstrate proficiency on at least three designated modules while meeting all safety, quality, and training requirements.

Skill Requirements

Key Responsibilities

  • Perform intermediate level electro‑mechanical assembly of robotic system modules including joints, control modules, and cable harnesses using engineering documentation and established work instructions with minimal supervision.
  • Operate within a structured production line environment to meet daily build targets while maintaining compliance with ISO 13485, FDA QSR, and Good Documentation Practices (GDP).
  • Interpret and apply defined assembly procedures to correctly build, verify, and validate mechanical and electromechanical components across multiple product modules.
  • Conduct functional, electrical, and mechanical tests using calibrated tools, test fixtures, torque equipment, and multimeters.
  • Identify, and troubleshoot basic electrical and mechanical issues (e.g., miswiring, misalignment, sensor faults) and escalate complex or systemic issues to engineering.
  • Perform minor mechanical and electrical repairs to support production continuity, escalating complex issues to engineering.
  • Maintain compliance with ESD controls, clean manufacturing protocols, and contamination‑control standards appropriate for medical device manufacturing.
  • Accurately document production activities, test outcomes, and inspection data in MES, ERP/SAP, and electronic DHR systems following GDP.
  • Perform in‑process inspections and contribute to quality verifications to ensure adherence to workmanship and regulatory standards.
  • Assist in process updates by providing feedback on assembly sequences, documentation accuracy, and fixture/tool improvements.
  • Support manufacturing engineering on the line setup, fixture validation, new product introduction (NPI) builds, and continuous improvement initiatives.
  • Support training, knowledge‑sharing, and guidance for new or entry-level technicians
  • Prepare production lines by performing line clearance, verifying equipment maintenance and calibration status, and ensuring material readiness—which includes accurate material transactions, cycle counts of raw materials, sub‑assemblies, and WIP, as well as proactively identifying and reporting shortages or discrepancies to prevent build interruptions and support efficient production scheduling.
  • Maintain certification and demonstrate proficiency on at least three designated modules while meeting all safety, quality, and training requirements.

Other Requirements

Source: the employer's careers page. Last checked 2026-10-28. Posted 2026-10-28.

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