Senior Manufacturing Engineer - Medical Device jobs in United States
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Kforce Inc · 5 hours ago

Senior Manufacturing Engineer - Medical Device

Kforce Inc is seeking a Senior Manufacturing Engineer - Medical Device to lead new product introduction and sustaining manufacturing activities for electro-mechanical based medical devices. The role involves designing, developing, implementing, and controlling manufacturing processes that meet quality, regulatory, and business requirements.

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H1B Sponsor Likelynote

Responsibilities

Lead the development, implementation, and optimization of manufacturing processes for both new and existing console medical devices
Partner closely with global suppliers to define and evaluate manufacturing processes, equipment, tooling, and fixtures to ensure consistent product quality
Plan and execute characterization studies, Design of Experiments (DoE), and process validations (IQ, OQ, PQ)
Develop and maintain manufacturing documentation, including work instructions, BOMs, routers, FMEAs, DMRs, and DHF documentation
Provide technical leadership to engineers and technicians supporting manufacturing operations
Design and introduce innovative processes, tooling, fixtures, and automation solutions
Train and guide manufacturing personnel on new processes, equipment, and standards
Drive functional excellence initiatives across product, process, and technical development
Track performance against KPIs and lead continuous improvement initiatives
Support departmental budget planning, resource allocation, and project scheduling

Qualification

Manufacturing EngineeringMedical Device ExperienceDesign of Experiments (DoE)Lean ManufacturingSix Sigma CertificationCAD SoftwareProblem-Solving MethodologiesCommunication SkillsOrganizational Abilities

Required

Bachelor's degree in Engineering (Mechanical, Electrical, or related discipline preferred)
6-8+ years of manufacturing or process engineering experience in a regulated environment; Specifically in medical device industry (pharmaceutical experience may be considered)
Hands on experience supporting both New Product Introduction (NPI) and sustaining manufacturing for medical devices
Experience with electronic and/or electromechanical medical devices or capital medical equipment
Strong background in DFM/DFA/DFMAT, Lean Manufacturing, DoE, process transfer, PFMEA, and structured problem-solving methodologies
Familiarity with all phases of Design Controls
Solid understanding of medical device Quality Management Systems and FDA regulations
Excellent written and verbal communication skills with strong organizational abilities
Thrives in a fast paced, cross-functional environment

Preferred

Six Sigma certification preferred
Experience with CAD software; SolidWorks or equivalent preferred

Benefits

Comprehensive benefits including medical/dental/vision insurance
HSA
FSA
401(k)
Life, disability & ADD insurance to eligible employees
Paid time off
Paid sick leave

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