Medical Device Equipment Engineer - Assembly & Process

TechDigital Group; Cincinnati (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

TechDigital Group in Cincinnati, OH seeks a Mechanical/Manufacturing/Industrial Engineer with 5–10 years in medical device equipment development and manufacturing to drive robust assembly processes.

You will lead DFA/DFM, FMEA, IQ/OQ/PQ, MSA and Gage R&R, manage suppliers, support product commercialization, and push continuous improvements in GMP, ISO 13485 and FDA-regulated environments. Strong cross-functional collaboration and risk management skills are essential.

Qualifications

• B.E./B.Tech in Mechanical, Manufacturing, or Industrial Engineering with 5-10 years in medical device manufacturing and equipment development.
• Experience in GMP, ISO 13485, and FDA-regulated environments.
• Proficient in DFA/DFM, FMEA, MSA, and process characterization.

Responsibilities

• Own the equipment development roadmap and qualification activities.
• Lead DFA assessment for assigned stations and feedback to design team.
• Drive process characterization and capital budget inputs for projects.
• Collaborate across cross-functional teams and with suppliers to ensure ramp-up readiness.

Skills

Equipment design

Process validation

DFM/DFMA

FMEA

MSA/Gage R&R

Risk management

Education

B.E./B.Tech in Mechanical/Manufacturing/Industrial Engineering

Job description

TechDigital Group in Cincinnati, OH seeks a Mechanical/Manufacturing/Industrial Engineer with 5–10 years in medical device equipment development and manufacturing to drive robust assembly processes.

You will lead DFA/DFM, FMEA, IQ/OQ/PQ, MSA and Gage R&R, manage suppliers, support product commercialization, and push continuous improvements in GMP, ISO 13485 and FDA-regulated environments. Strong cross-functional collaboration and risk management skills are essential.