Accept Alternate Job Title:In the job offered or related occupation
Normal Requirements of Job Opportunity:Y
Required Foreign Language:N
Specific Skills:Applicants must have demonstrated experience with the following Designing Verification and Validation; Developing of product requirements; Developing and execution of verification and validation activities; Requirements management and traceability; Computer and networked devices; Design for Six Sigma; Human factors engineering including user studies and usability documentation; Common risk management techniques FMEA, FTA, and ETA.;Generating customer requirements and writing product requirements specifications, test protocols, and test reports; International standards applicable to medical devices, including ISO13485, ISO14971, and IEC60601 and its collateral standards; Developing of complex instrument systems involving hardware, electronics, and optics, ideally in a healthcare, medical technology or life sciences area; Phase Gated Product Development process; Contracting with, and managing, third party hardware consultants within and outside the U.S.; Supervision from project leaders, provide engineering skills, technology development, and product evaluation support; Implementing , monitoring and deliver designated tasks and deliverables; Developing robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements; Designing, assembling and evaluating rapid prototype models in order to assess technical feasibility of various solutions; and Ensuring compliance with internal quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. Conduct handson evaluation of competitive products, materials and procedures.
