Sterling Engineering · 6 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.
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
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
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 StageRecent News
Hartford Business Journal
2025-01-28
Hartford Business Journal
2024-12-20
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