Product Development Engineer- Medical Devices & IVD Manufacturer, Los Angeles, CA
Product Development Engineer needed to oversee the development and manufacture of low cost, plastic devices including disposable blood collection devices.
Requirements
- At least 5 years of experience in the development of medical devices
- Bachelor’s degree in an engineering discipline preferred.
- Mechanical and/or electrical engineering background
- Experience in manufacturing, development, project management or commercial roles in a regulated (FDA, ISO) manufacturing environment.
- Computer aided design (CAD) / SolidWorks or similar software package
Additional Expertise: Knowledge & Skills
- Prototype design and testing
- Risk Analysis, FMEA, and process validation
- Design Verification, Product Validation and Usability (human factors) Testing
- Injection molding
- Selection of materials for medical devices based upon materials interface needs
- Automation and Assembly of products
- Design control
Essential Duties
- Work with R&D on conceptualization, planning and design of new products
- Identify, qualify, and supervise contract development firms and manufacturing partners
- Organize new project/product quoting with outside firms
- Assist in the development of budgets and product development timelines in Microsoft Project.
- Manage develop programs and transfer to manufacturing under cGMP
- Assist in the conceptualization of new products including providing modeling/design
- Ensure documentation of product design (including specifications and tolerances)
- Develop product requirements
- Assist in the development of product Quality Control Plan
- Inspection and auditing of contract manufacturers with team
What Do You Want To Do Next?
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Contact Paul/Submit Your Resume
Contact:
Paul Dionne
MEIRxRS
pdionne@meirxrs.com
[indeed-apply jobtitle=”Principal Development Engineer” emailapplicationto=”pdionne@meirxrs.com”]
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