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Supplier Development Engineer
Russell TobinPenangMalaysia, Penang, Malaysia20 jam yang lalu
Penerangan pekerjaanBachelor’s degree in Mechanical Engineering or related Engineering field with minimum 5 years of experience in medical device. OR advanced degree in Mechanical Engineering or related Engineering field with 5 years of experience in medical device design and development. Aptitude for Mechanical engineering fundamentals with a demonstrated history of successful application. Knowledge in human anatomy and physiology, surgical procedures, and surgical instrumentation. Understanding of the medical device industry. Proven ability to identify and apply innovative solutions to solve technical challenges. Experience designing, prototyping, developing and qualifying components as a part of a product or system. Proficient with 3D CAD design and modeling (SolidWorks proficiency preferred). Experience with rapid prototyping processes and hands-on prototype assembly. Machine shop experience is desirable. Proficient in creating and reviewing engineering drawings with GD&T. Proficient in evaluating designs using analytical tools and software, such as tolerance stacks. Skilled in test method development and experiment execution. Experience with Gage RR, BIAS and Design of Experiments desirable. Proficient in the application of basic and advanced statistical / data analysis (MS Excel). Proficient in data analysis and application of statistical software (MS Excel). Demonstrates strong technical report writing skill. Knowledgeable in metals, plastics, and manufacturing processes. Familiarity with medical device regulations and various technical standards. Knowledge of statistical process control in mass production as well as Six Sigma (DFSS) for design, validation, and optimization. Demonstrates strong communication and presentation skills, including the ability to discuss complex technical subjects with experts and non-experts.
Responsibilities
- Key member of Supplier Engineering team responsible for delivering a quality driven, cost-effective product that meets all agreed-upon customer requirements.
- Collaborate with R&D, Manufacturing, Supply Management, Quality, Operations, Marketing and Regulatory functions to be a valued team member.
- Develop and qualify high-complexity medical devices.
- Collaborate with peers to manage the development of testing to verify the product meets internal and external customer requirements.
- Train and mentor others in specialized areas.
- Adhere to safety policy and procedures.
- Continue to develop skills through additional training and educational programs.
Must Have (Minimum Requirements) :
Nice to Have (Preferred Qualifications) :
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Development Engineer • PenangMalaysia, Penang, Malaysia
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