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Senior Process Engineer jobs in United States
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Sterling Engineering · 21 hours ago

Senior Process Engineer

Sterling Engineering is seeking a hands-on Process / Manufacturing Engineer to support new product development and the launch of a new low-volume assembly line within a regulated medical device environment. This role involves collaborating across global sites to identify risks, apply best practices, and facilitate a smooth design transfer into manufacturing.
ConsultingInformation Technology
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Ric Delgado
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Responsibilities

Provide DFA / DFM feedback during product development and design reviews
Support design transfer from R&D into manufacturing, including pilot builds and ramp-up
Develop and optimize manual or semi-automated low-volume assembly lines and equipment
Lead or support IQ/OQ/PQ process validation activities
Develop pFMEAs, control plans, and risk documentation
Create and maintain work instructions and process documentation with operator input
Partner with vendors to design, build, and qualify assembly fixtures and equipment
Design and manage layouts, workflows, and material flow within a mini production facility

Qualification

Process EngineeringManufacturing EngineeringProcess ValidationNew Product DevelopmentPFMEARisk DocumentationCommunicationCollaboration

Required

Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or related field
5+ years of Process or Manufacturing Engineering experience (medical device or other regulated environment preferred)
Experience supporting new product development, NPI, or assembly line launches
Strong understanding of manual assembly and operator-heavy processes
Experience with process validation and statistical methods

Preferred

pFMEA and risk documentation experience

Company

Sterling Engineering

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Sterling Engineering is an engineering company providing technical recruitment and engineering project services.

H1B Sponsorship

Sterling Engineering 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 (3)
2024 (6)
2023 (3)
2022 (1)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Dolores Connolly
CEO
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Company data provided by crunchbase