Process Development Engineer jobs in United States
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Shoolin Inc ยท 12 hours ago

Process Development Engineer

positionMinnesota, United States
timeContract
remoteOnsite
senioritySenior Level
date5+ years exp

Shoolin Inc is seeking an experienced Process Development Engineer to support manufacturing process development and validation for Class III medical devices. The role focuses on process optimization, validation execution, and GMP-compliant documentation while working cross-functionally with R&D, QA, and Production teams.

Artificial Intelligence (AI)Big DataCloud ComputingInformation TechnologyInternet of ThingsSoftware
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H1B Sponsor Likelynote
Hiring Manager
Aadil Shaikh
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Responsibilities

Lead process development, optimization, and validation activities for Class III devices
Execute IQ/OQ/PQ, TMV, and risk management documentation
Develop and validate manufacturing processes, test methods, and equipment
Implement process improvements and automation solutions to reduce manual operations
Collaborate with R&D, QA, and Production to transfer processes into manufacturing
Ensure full compliance with GMP and ISO 13485 requirements

Qualification

Process validationClass III medical devicesGMP complianceISO 13485 complianceProcess developmentTest methods developmentCross-functional collaboration

Required

5+ years of process development / manufacturing engineering experience in the medical device industry
Hands-on experience with Class III medical devices
Strong expertise in process validation (IQ, OQ, PQ, PPQ, TMV/IMV)
GMP and ISO 13485 compliance and documentation experience
Ability to independently lead process development and validation activities
Experience developing or validating test methods, equipment, or fixtures

Company

Shoolin Inc

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Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.
dateFounded in 2010
location
Iselin, New Jersey, USA
people-size51-200 employees
web-link
https://shoolin-inc.com

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 Stage
Company data provided by crunchbase