Senior Design Quality Engineer
Smith & Nephew
Senior Design Quality Engineer (Smith & Nephew, Inc., Cordova, TN): Develop the full reliability and inspection plan for all new products (instrumentation and implants for multiple systems). Responsible for evaluating products, manufacturing processes, assembly processes, and leading quality control activities through training, inspection procedure preparation, and technical support. Work with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Lead each of these groups with capability studies and measurement analysis studies. Work with Regulatory Affairs to support UL, IEC, and FDA submissions. Participate in internal audits conducted by internal employees and regulatory agencies. Collaborate with Manufacturing Engineers to review processes for new products and handle process validations and capability studies. Recommend process monitoring devices, where applicable. Lead Gage Design for products. Mentor junior engineers. Lead application of statistical quality control. Work with the Regulatory Affairs team to develop regulatory body responses. Manage projects. Provide guidance to suppliers for process development and technologies. Lead Product Reviews with Management throughout Design Review Process.
Must have a Bachelor of Science degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, Industrial Engineering or a related field plus 5 years of post-baccalaureate experience in the job offered or related role in the Medical Device Industry. Alternatively, will accept a Master’s degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, Industrial Engineering or a related field plus 3 years of experience in the job offered or related role in the Medical Device Industry.
Of the required experience, must have 3 years of experience in the following:
- Quality System Regulations and International Standards Organization requirements
- Shopfloor Control
- Post market research/product reviews
- Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
- Machining and inspection
- Medical device and anatomical knowledge
- Gauging methodologies
- Working in a regulated Quality Management System
- Design and process risk assessments
- Geometrical dimensioning and tolerancing
- Data analysis/statistical analysis
- Product and process validation in a regulated industry
- Product packaging and labelling reviews
Of the required experience, must have 2 years of experience in drafting/design principles using software such as Unigraphics.
20% Telecommuting permitted (Memphis, TN area).
Must be willing and able to travel up to 10% of the time (95% domestic; 5% international) to travel to client sites and other Smith & Nephew offices.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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