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• Key member of Supplier Engineering team responsible for delivering a quality driven cost-effective product that meets all the agreed upon customer requirements.
• Work effectively with R&D, Manufacturing, Supply Management, Quality, Operations, Marketing and Regulatory functions to be a valued team member.
• Develops and qualifies high complexity medical devices.
• Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
• Train and mentor others in specialized area.
• Adhere to safety policy and procedures.
• Continue to develop skills through additional training and educational programs.
• Bachelor's degree in Mechanical or Biomedical Engineering
• 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)
• Experienced 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 comprehensive 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 appropriate use 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 and validation and optimization.
• Demonstrates strong communication and presentation skills, including the ability to discuss complex technical subjects with experts and non-experts.
Job ID: 151790975