OEM Engineer - Entry Level (Onsite)
On-siteHouston, Texas, United States
Job Summary
Manage OEM projects from early feasibility to clinical production, creating and maintaining project timelines, budgets, and deliverables. Develop and document OEM products and manufacturing processes, designing electrical or mechanical fixtures and equipment while drafting process validation protocols. Perform root cause analysis to resolve manufacturing and quality issues, improving cost, quality, and delivery in adherence to cGMP, FDA, and ISO requirements. Prepare cost estimates, reports, proposals, and presentations to support business development, research, and sales initiatives. Address production and customer problems related to product design, with the ability to travel up to 10% domestically and internationally.
Required Qualifications
- Bachelor's Degree in Mechanical, Electrical, Biomedical Engineering or equivalent
- 1 – 3 years of experience in medical device manufacturing or design
- Knowledge of developing a process from concept to full production release
- Project Management skills
- Advanced working knowledge of Microsoft Office, SolidWorks, project management software
- Capable of successfully managing concurrent projects independently and in a team environment
- Excellent oral and written communication skills
- Attention to detail
- Focus on quality
- Ability to travel up to 10% domestically and internationally
Desired Qualifications
- catheter manufacturing
- Knowledge of 21 CFR, ISO-13485
- Experience conducting Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV)
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