Shoolin Inc · 1 week ago
Process Engineer
Shoolin Inc is seeking a hands-on Equipment Process Engineer to support and optimize manufacturing equipment and processes within their medical device production environment. The role requires strong mechanical and electrical engineering skills to collaborate with Production, Quality, and R&D teams, ensuring compliance and efficiency in manufacturing processes.
Responsibilities
Provide engineering support for automated and semi‑automated manufacturing equipment across multiple stations
Lead hands-on mechanical, electrical, and pneumatic troubleshooting, ensuring maximum equipment uptime
Support and optimize welding processes (e.g., ultrasonic welding, laser welding, heat staking) to ensure consistent bond quality and compliance with device specifications
Own and improve crimping processes, including tool selection, die validation, pull testing, and ongoing capability monitoring
Perform equipment setup, calibration, and validation activities including IQ/OQ/PQ
Develop, sustain, and optimize manufacturing processes related to welding, crimping, assembly, testing, and material handling systems
Support preventive and predictive maintenance programs for welding and crimping equipment
Lead root cause analysis and implement permanent corrective actions for equipment or process failures
Create and maintain SOPs, work instructions, PM schedules, engineering change orders, and validation documentation
Participate in capital equipment projects, upgrades, and continuous improvement initiatives
Ensure compliance with FDA, ISO 13485, and GMP regulatory requirements
Qualification
Required
Bachelor's degree in Mechanical Engineering, Electrical Engineering, Mechatronics, Biomedical Engineering, or related field
2–5+ years of experience as an engineer in medical device manufacturing or other regulated environments
Strong hands-on skills with mechanical systems, electrical troubleshooting, sensors, pneumatics, actuators, and machine components
Direct experience supporting or validating welding processes (ultrasonic, laser, resistance, or thermal)
Working knowledge of crimping processes, wire termination tooling, pull‑test requirements, and process capability analysis
Ability to support multiple production lines/stations simultaneously
Strong ability to read mechanical drawings, electrical schematics, and equipment documentation
Excellent analytical, communication, and documentation skills
Preferred
Experience supporting automated welding cells, crimp force monitoring, or other precision joining technologies
Familiarity with PLC-driven equipment, robotics, machine vision, or automated assembly
Knowledge of DOE, SPC, Six Sigma, and other process engineering methodologies
CAD experience (SolidWorks, AutoCAD)
Experience working in cleanroom environments for Class II or III medical devices
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