Envista
Nobel Biocare Process Development Engineer (On-Site Mahwah, NJ)
Envista, Mahwah, New Jersey, United States, 07430
Job Opportunity: Process Development Engineer
The Process Development Engineer is responsible for supporting the development and execution of manufacturing processes for individualized dental products regulated by the FDA that are produced through a Computer Automated Manufacturing Cell or Line. The Engineer assists in defining and documenting manufacturing steps while contributing to automation equipment selection, including robots, conveyors, and PLC-based systems. Working collaboratively with the CAM Development Team, Product Development teams, and Product Sustainment teams, the Engineer ensures efficient production, quality standards, and cost optimization while providing hands-on technical support to manufacturing teams. Primary Duties and Responsibilities: Assist in defining manufacturing execution sequences (CAM, CNC, additive manufacturing, tooling, sintering, etc.) based on PFMEA, product, and process requirements. Develop and release documents that will be reviewed and audited by the FDA. Assist the Quality team as the process SME (subject matter expert) for the released production line during an audit. Conduct shop floor implementation tests for new and existing manufacturing processes, documenting findings in technical reports. Provide technical support for production, troubleshooting quality or manufacturing issues, and collaborating with cross-functional teams. Support production teams in optimizing processes and ensuring stable, efficient operations for dental prosthetic products. Participate in Site Acceptance Tests for new manufacturing processes, ensuring compliance with quality standards. Conduct pre-study analysis to assess cost/benefit ratios and risk factors for new product launches or process improvements. Develop documentation and technical drawings related to manufacturing processes and equipment. Adhere to project timelines and objectives, delivering results aligned with business needs. Other relevant tasks or duties as assigned by the Process Development Manager. Some travel (up to 10%) may be required, including internationally. Job Requirements: Bachelor of Science in Mechanical or Manufacturing Engineering or related field. 3+ years of experience in CAD/CAM machining with 5-axis CNC milling machines and related manufacturing processes in a medical device environment. 3+ years in a manufacturing engineering or process development role within a regulated industry, preferably medical devices. Experience with Process Failure Mode Effects Analysis (PFMEA). Hands-on experience conducting validations and writing professional test reports. Must be able to create 3D models and GD&T drawings. Basic knowledge of equipment qualifications (IQ/OQ/PQ) and process validations. Understanding of production transfer for new products and manufacturing process development in an FDA regulated environment. Familiarity with ceramic and titanium processing techniques in manufacturing. Exposure to statistical tools, lean manufacturing principles, or ES tools. Preferred Qualifications: Lean/Six Sigma certification preferred. Experience with root cause analysis and problem-solving methodologies. Strong communication, documentation, and analytical skills, with the ability to explain technical concepts clearly. Time management, planning, and organizational skills to handle multiple projects. Working knowledge of Delcam is preferred. Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with SAP or similar ERP systems is preferred. Openness to sharing knowledge and collaborating with colleagues. Ability to work both independently and as part of a team, contributing to problem-solving initiatives. Strong attention to detail, organization, and follow-through in manufacturing projects. Willingness to work flexible hours to support business needs. Target Market Salary Range: $73,900 - $110,800 Operating Company: Nobel Biocare 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 total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
The Process Development Engineer is responsible for supporting the development and execution of manufacturing processes for individualized dental products regulated by the FDA that are produced through a Computer Automated Manufacturing Cell or Line. The Engineer assists in defining and documenting manufacturing steps while contributing to automation equipment selection, including robots, conveyors, and PLC-based systems. Working collaboratively with the CAM Development Team, Product Development teams, and Product Sustainment teams, the Engineer ensures efficient production, quality standards, and cost optimization while providing hands-on technical support to manufacturing teams. Primary Duties and Responsibilities: Assist in defining manufacturing execution sequences (CAM, CNC, additive manufacturing, tooling, sintering, etc.) based on PFMEA, product, and process requirements. Develop and release documents that will be reviewed and audited by the FDA. Assist the Quality team as the process SME (subject matter expert) for the released production line during an audit. Conduct shop floor implementation tests for new and existing manufacturing processes, documenting findings in technical reports. Provide technical support for production, troubleshooting quality or manufacturing issues, and collaborating with cross-functional teams. Support production teams in optimizing processes and ensuring stable, efficient operations for dental prosthetic products. Participate in Site Acceptance Tests for new manufacturing processes, ensuring compliance with quality standards. Conduct pre-study analysis to assess cost/benefit ratios and risk factors for new product launches or process improvements. Develop documentation and technical drawings related to manufacturing processes and equipment. Adhere to project timelines and objectives, delivering results aligned with business needs. Other relevant tasks or duties as assigned by the Process Development Manager. Some travel (up to 10%) may be required, including internationally. Job Requirements: Bachelor of Science in Mechanical or Manufacturing Engineering or related field. 3+ years of experience in CAD/CAM machining with 5-axis CNC milling machines and related manufacturing processes in a medical device environment. 3+ years in a manufacturing engineering or process development role within a regulated industry, preferably medical devices. Experience with Process Failure Mode Effects Analysis (PFMEA). Hands-on experience conducting validations and writing professional test reports. Must be able to create 3D models and GD&T drawings. Basic knowledge of equipment qualifications (IQ/OQ/PQ) and process validations. Understanding of production transfer for new products and manufacturing process development in an FDA regulated environment. Familiarity with ceramic and titanium processing techniques in manufacturing. Exposure to statistical tools, lean manufacturing principles, or ES tools. Preferred Qualifications: Lean/Six Sigma certification preferred. Experience with root cause analysis and problem-solving methodologies. Strong communication, documentation, and analytical skills, with the ability to explain technical concepts clearly. Time management, planning, and organizational skills to handle multiple projects. Working knowledge of Delcam is preferred. Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with SAP or similar ERP systems is preferred. Openness to sharing knowledge and collaborating with colleagues. Ability to work both independently and as part of a team, contributing to problem-solving initiatives. Strong attention to detail, organization, and follow-through in manufacturing projects. Willingness to work flexible hours to support business needs. Target Market Salary Range: $73,900 - $110,800 Operating Company: Nobel Biocare 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 total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.