Manufacturing Engineer Jobs

Hi,

I came across your profile and wanted to reach out regarding a unique opportunity. You can find the job description below. If you’re interested in learning more, I’d love to connect. Would you be available for a quick phone call?

Job Title:Manufacturing Engineer

Location:Warsaw, IN

Duration:Long term

Client: Zimmer

Technical/Functional Skills:

Equipment Qualification (IQ, OQ and PQ) and support writing and executing IQ/OQ/PQ’s and other general ME tasks

Experience Required

• Working experience in medical device industry with expertise in EU MDR, Design Controls, Risk Management, Document Control, CAPA, Complaint Handling, Post-Market Surveillance, Six Sigma, Trending, Field Actions, PMCF, CER, supplier quality, DMR, DHR and Change Management System.
• Experience in compliance with ISO (13485 and 14971), FDA (21 CFR 820), EU MDR, GMP & ASTM medical device standards related to physical device testing.
• DHF Remediation, Design Control documents, Risk Management documents and Internal/External Audits.
• Experience in IE, CAPA and complaint handling activities.
• ISO Standards (ISO13485, ISO14971), QMS, ASTM, FDA Regulations (21CFR 820.30, 21CFR 820.40, 21 CFR 820.100, 21 CFR 820.198 and 200) EU MDR (European Union Medical Device Regulations) and GD&T in accordance to ASME Y 14.5 standards.
• Creation and updating DHF documents which includes Design Control and Risk Management documents (Design & Development plan/report, User Needs, Design Input/Output, Design transfer, Design Verification & Validation protocol/report and Risk Management Plan/Report, Design & Use FMEA, Risk Benefit Analysis (Individual and Overall)).
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Developing product requirements, test protocols and reports, and risk analyses to create and update DHF flies by being compliant with ISO 13485, ISO 14971, FDA Quality System Regulations, and internal standards.