Sr. Electromechanical Manufacturing Engineer (FDA) jobs in United States
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Kforce Inc ยท 3 hours ago

Sr. Electromechanical Manufacturing Engineer (FDA)

Kforce Inc is seeking a Senior Electromechanical Manufacturing Engineer (FDA) to create and implement manufacturing processes for medical devices. The role involves collaboration with suppliers, leading engineering teams, and ensuring compliance with FDA regulations.

ConsultingEmploymentFinancial ServicesHuman ResourcesStaffing Agency
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H1B Sponsor Likelynote

Responsibilities

Create and implement new manufacturing processes for medical devices
Collaborate with global suppliers to define manufacturing processes, equipment, and tools/fixtures to ensure quality products
Perform characterization studies, Design of Experiments (DoE), and validation/verification of processes and inspection methods (IQ, OQ, PQ)
Develop manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents
Lead teams of engineers and technicians on manufacturing activities
Innovate, design, and develop processes, procedures, tooling, and automation
Train and provide direction to manufacturing personnel
Drive functional excellence initiatives for product/process and technical development
Monitor KPIs/metrics and implement improvement projects as needed
Assist in developing department budgets, schedules, and resource plans
Perform other duties as assigned

Qualification

FDA experienceDesign for ManufacturingLean ManufacturingDesign of ExperimentsQuality Management SystemsFMEAElectromechanical systemsCAD softwareSix Sigma CertificationCommunication skillsOrganizational skills

Required

Bachelor's degree in Engineering (Mechanical, Electrical, or related field)
6+ years as a process/manufacturing engineer in a regulated environment; FDA experience in pharma or medical device industry required
Expertise in Design for Manufacturing, Assembly, and Test (DFMAT), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer, FMEA, and problem-solving methodologies
Strong understanding of Quality Management Systems, design controls, and product development processes
Solid knowledge of FDA regulations, guidelines, and policies for medical devices
Experience with electromechanical systems and durable materials required
Excellent verbal/written communication and organizational skills

Preferred

Proficiency with CAD software (SolidWorks preferred)
Six Sigma Certification preferred

Benefits

Medical/dental/vision insurance
HSA
FSA
401(k)
Life, disability & ADD insurance

Company

Kforce Inc

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Kforce is a solutions firm specializing in technology, finance and accounting, and professional staffing services.

H1B Sponsorship

Kforce Inc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (792)
2024 (667)
2023 (734)
2022 (843)
2021 (1197)
2020 (858)

Funding

Current Stage
Public Company
Total Funding
unknown
2024-05-20IPO
2014-06-08Acquired

Leadership Team

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Aaron Travis
Digital Experience Delivery Director | Kforce Consulting Solutions
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Company data provided by crunchbase