Equipment Engineer

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

Job summary

Belcan is seeking an Equipment Engineer to act as the liaison between the Design team and equipment suppliers in Cincinnati, OH. You will provide a voice of manufacturing to influence design while ensuring DFM/DFA feedback aligns with design intent.

The role requires 6+ years in automated manufacturing equipment within regulated industries, with hands-on experience in FAT/SAT, IQ/OQ/PQ, and DFx principles. Medical domain experience is preferred.

Qualifications

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

Responsibilities

• Understand the equipment development road map and validation stages (IQ/OQ/PQ) road map requirements.
• Deliver robust assembly process and equipment meeting cycle time, cost, capacity, and quality targets.
• Lead the DFA assessment for each station and feedback to the design team.
• Oversee equipment suppliers through design reviews, build, FAT, and SAT.
• Identify and mitigate development risks; escalate resource needs and manage changes.

Skills

Voice of manufacturing

DFM knowledge

DFA knowledge

IQ/OQ/PQ understanding

Project coordination

Education

Bachelor in Engineering or equivalent

Tools

FAT

SAT

EFMEA/WRAPS/Safety/Ergo assessments

Job description

Our customer is looking for an Equipment Engineer to act as the liaison between the Design team and the component/equipment suppliers. This individual will provide a \"voice of manufacturing\" to influence design and include DFM/DFA feedback while maintaining Design Intent.

• Fully understand the equipment development road map. Understand equipment concept creation, review approval, build, run off, FAT, software validation, IQ, OQ, PQ road map requirements.
• Fully understand the equipment development procedure WE0179 and associated deliverables including ERR, ESRR, EFMEA, and WRAPS/Safety/Ergo assessments.
• Delivers robust assembly process and associated equipment that achieves cycle time, cost, capacity, and quality requirements (MSA, GRR). Continues ownership and support of equipment beyond IQ/OQ/PQ qualification and throughout stabilization period. This includes handling scrap and supply disruptions, equipment/process improvement projects, and overall stabilization of process while ramping up production prior to LCE/Plant handoff.
• Knowledgeable about medical specific assembly technologies, the equipment supplier base and the capabilities of the suppliers.
• Knowledgeable about equipment cost and lead time. Provides significant input to the capital budget estimate.
• Understand the connection between product requirements to each assembly station. Generate equipment requirements. Leads the DFA assessment for each assigned station, provides feedback to the design team.
• Oversight and leadership of the process characterization strategy for each assigned station.
• Delivers component, assembly, and supply chain strategy project deliverables at each phase of the project.
• Drive critical product requirements cascading to component and assembly processes. Understand how to transform design information (component drawings and models, product requirements, AFMEA, DFMEA) into a robust manufacturing process.
• Identifies and escalates potential development related risks and provides input to the project RISDA. Develops strategies to mitigate those risks. Proactively develops strategies to rapidly react to design changes and provide flexibility through use of standardized/family tools, insert strategies, modularity, etc.
• Assists the LDE and Project Director with identifying required development resources. Escalates needs appropriately to help with prioritization of development team tasks.

Required Qualifications:

• Bachelor in Engineering or equivalent
• 6+ years of experience developing, specifying, and launching automated manufacturing equipment in a regulated industry (medical device, pharmaceutical, biotech, or similar).
• Experience leading equipment suppliers through equipment design reviews, build phases, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
• Demonstrated experience with IQ/OQ/PQ validation protocols and equipment qualification activities.
• Experience applying Design for Manufacturing (DFM) and Design for Assembly (DFA) principles during product development.
• Medical domain experience

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.