Shoolin Inc ยท 1 day ago
Manufacturing Engineer
Shoolin Inc is seeking a Manufacturing Engineer to support process development, standardization, and workforce training in a regulated medical device manufacturing environment. The role focuses on process flow development, operator training using TWI principles, and standardized documentation to ensure consistent and compliant manufacturing execution.
Responsibilities
Develop and maintain detailed manufacturing process flows across product lines
Create, customize, and deploy TWI-based training and standard work for operators
Build and maintain a process dictionary to standardize terminology and execution
Support process mapping from pilot builds through full-scale production
Collaborate with Manufacturing, Quality, R&D, and Operations teams
Ensure compliance with FDA and ISO 13485 requirements
Support continuous improvement and process validation activities
Qualification
Required
Bachelor's degree in Mechanical Engineering
3+ years of experience in medical device manufacturing or regulated environment
Hands-on experience with TWI (Training Within Industry) or structured operator training
Strong experience developing manufacturing process flows and work instructions
Experience with standardized manufacturing documentation and process dictionaries
Knowledge of FDA regulations and ISO 13485
Company
Shoolin Inc
Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.
H1B Sponsorship
Shoolin 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 (81)
2024 (45)
2023 (48)
2022 (36)
2021 (29)
2020 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase