Manufacturing Engineer II (Second Shift) jobs in United States
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Cordis · 2 months ago

Manufacturing Engineer II (Second Shift)

positionIrvine, California
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

Cordis is a company specializing in the development of advanced drug device combination products for treating coronary and peripheral artery disease. They are seeking a Manufacturing Engineer II (Second Shift) to develop, evaluate, and optimize manufacturing processes while ensuring robust production transitions and compliance with quality control standards.

Health CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote

Responsibilities

Develop highly capable manufacturing processes for existing products in manufacturing. Ensure robust transition from product development thru full rate production ensuring process stabilization
Develop, and qualify new tooling and equipment
Update FMEA’s and QCP’s for NPI
Verification/Validation of processes, machines, and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols
Create and sustain routers and standards
Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans
Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems

Qualification

Class IIIIIb Implantable Medical Device experienceValidation/Verification process knowledgeGage R&R knowledgeFDA’s QSRGMP understanding’s Degree in Engineering5 years manufacturing experienceClean room environment experienceIndependent decision makingFluent in EnglishVerbal communicationWritten communicationOrganization skillsAttention to detailProject management skills

Required

Bachelor's Degree in Engineering or related science discipline
Minimum 5 years of experience in a manufacturing environment
Class III, IIb Implantable Medical Device experience
Previous experience working in a clean room environment
Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization
Strong organization and follow-up skills, as well as attention to detail
Ability to take independent decisions
Own project level goals involving multiple engineers
Break down ambiguous tasks into clear milestones to ensure progress can be measured
Knowledge of Validation/Verification process, Gage R&R, and a clear understanding of FDA's QSR and GMP
Strong analytical, problem solving, and project management skills
Fluent in English

Company

Cordis

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Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
dateFounded in 1959
location
Hialeah, Florida, USA
people-size1001-5000 employees
web-link
https://www.cordis.com/

H1B Sponsorship

Cordis 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 (5)
2024 (3)
2023 (3)
2022 (4)

Funding

Current Stage
Late Stage
Total Funding
unknown
2021-03-12Acquired

Leadership Team

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Scott Drake
Chief Executive Officer
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Recent News

PR Newswire
iRiva Medical Announces Close of Initial Financing Round
2025-11-11
TeamBest Global Companies
Best Vascular/Novoste Marks 25 Years Since FDA Approval of Vascular Brachytherapy
2025-11-07
News-Medical.Net
Sirolimus-eluting balloon emerges as a safe and effective option for coronary in-stent restenosis
2025-11-01
Company data provided by crunchbase