Medical Equipment Engineer: DFA/DFM & FAT Lead

Belcan Corporation; Cincinnati (OH); On-site; USD 69,000 - 83,000; Full time

Job summary

Belcan Corporation is seeking an Equipment Engineer in Cincinnati, OH to bridge the Design team and equipment suppliers. You will shepherd the equipment development road map, support FAT/SAT, and ensure IQ/OQ/PQ validation aligns with design intent.

You will lead DFA reviews, cost and lead-time input for capital budgets, and drive robust manufacturing processes for high-quality medical devices. Immediate start preferred, 24-month contract.

Qualifications

• Bachelor in Engineering or equivalent.
• 6+ years of experience developing, specifying, and launching automated manufacturing equipment in a regulated industry.
• Experience leading equipment suppliers through design reviews, build phases, FAT/SAT.
• Demonstrated IQ/OQ/PQ validation protocol experience and equipment qualification activities.
• Experience applying DFM and DFA during product development.
• Medical domain experience.

Responsibilities

• Understand the equipment development road map and review approval, build, run off, FAT, software validation, IQ/OQ/PQ road map requirements.
• Understand WE0179 and related deliverables including ERR, ESRR, EFMEA, and WRAPS/Safety/Ergo assessments.
• Deliver robust assembly processes and equipment meeting cycle time, cost, capacity, and quality targets.
• Lead DFA assessment for each station and provide feedback to design team.
• Drive process characterization strategy for each station and deliver project outputs for equipment strategy.
• Translate product requirements into equipment and assembly process specifications and manage risk mitigation.
• Assist with identifying required development resources and escalate as needed to prioritize tasks.

Skills

Manufacturing equipment experience

Regulated industry experience

Project leadership

DFM/DFA knowledge

Education

Bachelor in Engineering

Job description

Belcan Corporation is seeking an Equipment Engineer in Cincinnati, OH to bridge the Design team and equipment suppliers. You will shepherd the equipment development road map, support FAT/SAT, and ensure IQ/OQ/PQ validation aligns with design intent.

You will lead DFA reviews, cost and lead-time input for capital budgets, and drive robust manufacturing processes for high-quality medical devices. Immediate start preferred, 24-month contract.