Implant Direct is part of Envista’s portfolio of dental product and service companies, including more than 30 trusted brands and over 125 years of dental excellence. With over 4.6 million implants placed worldwide, Implant Direct enables dentists to advance their patients’ oral health with high-quality dental implant solutions. All implants are manufactured in the USA using only medical-grade titanium alloy, meeting the industry’s highest performance and safety standards. We offer a unique portfolio of products and solutions that elevate the performance of your practice through predictable outcomes, greater patient satisfaction, and reduced total costs. We are committed to renewing confidence and changing lives through enhancing patient access. For more information about Implant Direct, visit www.Implantdirect.com Job Description: JOB SUMMARY: Perform technical activities of assigned projects to ensure medical device is in compliance with applicable regulatory requirements and quality control standards. Conduct design and development activities. Assist in the preparation and review of engineering documentation and performs a variety of complicated tasks requiring a wide degree of creativity and latitude. Develops specifications and perform design verification and validation tests for product line extensions as well as design changes to currently marketed products. Act as the technical support for Quality, Manufacturing and Manufacturing Engineering, Customer Service, Marketing and Procurement departments to improve product quality while adhering to internal quality system procedures in a regulated medical device industry. Essential Duties: Responsible for conducting product sustainment or development activities and generating documentation ensuring compliance with internal operating procedures, ISO13485 and FDA 21 CFR Part 820.30. Lead product line extension or design change projects in cross functional teams. Create or verify dimensions of parts, materials to be used, relations of one part to another, and relation of various parts to whole structure of product lines. Review, provide feedback and approve Change Order documentations. Conduct risk assessment and document results ensuring compliance with internal procedures and ISO 14971. Conduct or participate in DFMEA (Design Failure Mode Effect Analysis) activities, including structural analysis, mechanical testing, tolerance studies and documentation. Provide necessary product documentation for Design History File according to internal procedures and in compliance with MDD and applicable standards (21 CFR 820, ISO 14971; and ISO 13485). Lead or participate in troubleshooting, failure analysis, root cause analysis, CAPA, customer complaint investigation, and process improvement Kaizen events. Generate documentation for Regulatory submissions and remediation projects. Implement regulatory requirements and product information into Instructions for Use. Participate in audits as subject matter expert (SME) for product sustainment. Conduct Finite Element Analysis and Tolerance Studies Generate documentation of Technical Files per CE Marking requirements. Responsible for product complaints follow up and corrective action documentation. Develop and generate engineering protocols/reports and submit Change Orders documentation. Generate drawings, models, sketches and designs based on pertinent standards. Respond to Discrepancy Reports for nonconforming products. Participate in Material Review Board activities as needed. Job Requirements: Minimum requirements: Bachelor’s degree in Mechanical Engineering or related engineering field 4 years experience in manufacturing engineering 2 years experience working with SolidWorks program Experienced in implementing and sustaining production processes including overseeing processes done at subcontractors Must be able to work on-site at our Thousand Oaks facility Preferred requirements: Medical Device experience preferred Experience with lean methodologies such as single piece flow, SMED, 5S, visual management, Gemba walk, and quality at the source CNC manufacturing methodology and machining methods is required; experience with Swiss machines is a plus Must be able to fully interpret engineering drawings or blueprints Familiar with titanium machining is a plus MS Word, Excel, and Outlook experience Good communication skills. Experience with statistical or six sigma tools such as gage R&R, hypothesis testing, pareto charts, cause and effect diagram, and FMEA is a plus #LI-CY1 IND123 Operating Company: Implant Direct Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf. Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. 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