Company: | CEPHIED |
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Job Role: | Senior Engineer - Biomedical (Diagnostic Consumables) Engineer. |
Experience: | (3-5 years). |
Vacancy: | 16+ |
Qualification: | Have a Bachelor's Degree in Any Engineering or related |
Salary: | $1,12,500/year. |
Location: | Sunnyvale, California, USA. |
Join us on Telegram | Click Here |
Apply Mode: | (Online) |
Deadline: | Not Mentioned |
- Senior Engineer - Biomedical (Diagnostic Consumables) is responsible for transforming product requirements into high-scale, sustainable production of consumables using injection molded plastics. Engineer custom solutions, improve current designs, and enable large scale manufacturing of medical device consumables using your knowledge of mechanical design, materials, automation, and molding.
- This position is part of the Consumables Engineering team and will be located in Sunnyvale, California.
- Develop and optimize part attributes to improve manufacturability and reduce costs in support of New Product Development (NPD) efforts; collaborate with design engineers to optimize manufacturing processes and design drawings so that high quality parts are consistently delivered.
- Use hands-on experience with material selection, characterization, prototype testing, design for manufacturing (DFM), assay system integration, and validations to transition designs from the Concept phase through Design and Development, and into Production.
- Drive FDA and ISO-compliant parts and process qualification from concept to completion.
- Assure that all consumable products meet high standards of design, quality, patient safety, and functional integrity.
- Have a Bachelor's degree in Engineering with 5-8 years of related work experience OR Have a Master's degree in Engineering with 3+ years of related work experience OR Have a Doctoral degree in Engineering with 0-2 years of related work experience
- Understanding of applicable FDA regulations and Company operating procedures, processes, and policies.
- Have experience with design control processes, design of experiments (DOE) and interpreting test results.
- Successfully transferred product from R&D to manufacturing.
- Experience in biomedical or mechanical engineering in an FDA-regulated medical device or diagnostics company
- Working knowledge of GD&T (Geometric Dimensioning and Tolerancing), quality measurement techniques, and SolidWorks.
- Proficiency with data analysis software such as Matlab, R, MINITAB, or Excel in order to conduct statistical analyses on collected data.
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