Shoolin Inc · 12 hours ago
Manufacturing Engineer
California, United States
Contract
Onsite
Mid Level
3+ years expShoolin Inc is seeking an experienced Manufacturing Engineer to support medical device manufacturing operations. The role will focus on process validation, regulatory compliance, and continuous improvement initiatives within a regulated environment.
Artificial Intelligence (AI)Cloud ComputingBig DataSoftwareInternet of ThingsInformation Technology
Hiring Manager
Aadil Shaikh
Responsibilities
Lead and execute IQ/OQ/PQ process validations
Ensure compliance with FDA and ISO quality standards
Support manufacturing process improvements and optimization
Apply statistical tools for process analysis and control
Drive continuous improvement initiatives using Lean/Six Sigma principles
Qualification
Required
3+ years of manufacturing engineering experience in the medical device industry
Strong experience with process validation (IQ/OQ/PQ) and statistical methods
Working knowledge of FDA 21 CFR Part 820 and ISO 13485
Experience with Lean Manufacturing and/or Six Sigma methodologies
Company
Shoolin Inc
Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.
51-200 employees
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