MECHANICAL DESIGNER Position Available In Anderson, Tennessee

Mechanical Designer – Oak Ridge, TN As a Mechanical Designer, you will participate with a cross-functional team on the new-product transition from the design owner/legal Device Manufacturer to our company. This includes obtaining an overall understanding of the device, its intended use, and theory of operation. You will determine how the current Device Master Record documentation will be transitioned into our quality management system and ERP system and identify any potential gaps that should be addressed for our staff’s training, skills, and expertise related to manufacturing, testing, and servicing the specific technology. Responsibilities Create error-free solid models. Support the implementation of plans for new-product transition. Identify specialized technologies inherent to products to be manufactured and gain technical understanding and confidence to be a technical reference on those products. Identify and develop test fixtures (including needed software) for subassembly verification prior to final system integration. Develop and validate final system test methodology and procedures. Implement the Product Engineer’s strategy for training manufacturing, testing, and servicing employees on device changes. Provide technical support to staff in the field during service events. Source and validate alternate components to alleviate end-of-life components. Investigate actual product performance and reliability issues and develop appropriate mitigations. Review the product for potential performance or reliability issues and develop preventive mitigations. Review the product for potential improvements and design and implement those improvements. Review suggested changes to the device, including the impact on the Design History File, device master record, compliance testing reports, regulatory submission documents, and risk management reports. Plan and perform necessary verification and validation for changes prior to implementation. Participate in the review of in-house non-conforming products, determine how to disposition the issue, and discuss with a cross-functional team what mitigations could be implemented for the prevention of future occurrences, and determine if the risk/benefit analysis supports the implementation of the potential mitigations. Essential Skills Mastery of SolidWorks and its capabilities. Experience in the design of electromechanical products and systems. Degree in Mechatronics or Mechanical Engineering or relevant experience. 7+ years of experience in an engineering role in a manufacturing industry, ideally in a regulated industry like medical devices. Experience with multiple types of manufacturing technologies (CNC, injection molding, sheet metal, machining, casting, etc.). Ability to create solutions within the confines of design constraints. Ability to design automated test fixtures. Ability to read standards that apply to specific products and apply the requirements to the product design. Proficiency in Microsoft Office Suite. Ability to manage multiple assignments simultaneously. Additional Skills & Qualifications Experience in the medical device or highly regulated industry. Experience with Vault. Work Environment This role is based in an on-site manufacturing facility, with working hours from Monday to Friday, 8 AM to 5 PM. The environment involves utilizing various manufacturing technologies and requires adherence to safety and quality standards.