Envista Holdings
Senior R&D Process Development Engineer
Envista Holdings, Brea, California, United States, 92631
Job Description:Overview:
As a
Senior R&D Process Development Engineer
specializing in orthodontic dental manufacturing, you will be leading the innovation, contributing to the development of cutting-edge products that enhance oral health. Your expertise will play a crucial role in improving existing processes, creating novel solutions for orthodontic devices, and overseeing the development and release of advanced manufacturing machinery to production. This is a hybrid position and requires someone in the office 3 days per week.Leadership Responsibilities:Lead
and
mentor
a team of engineers and technicians.Drive
the execution of projects and manage resources to ensure goals are met on time and within budget.Foster
a culture of continuous improvement and innovation.Communicate
effectively with all levels of the organization, from entry-level employees to senior executives.Collaborate
with cross-functional teams to align on strategy and implementation.Technical Responsibilities:Machine Development and Production Release:Lead the design, development, and implementation of advanced manufacturing machinery.Oversee the transition of machinery from development to production, ensuring smooth integration into existing processes.Collaborate with cross-functional teams to troubleshoot and resolve machinery and production issues.Ensure machinery meets all safety, quality, and efficiency standards before release to production.Research and Analysis:Conduct thorough research specific to orthodontic materials, manufacturing techniques, and patient needs.Analyze data related to dental biomechanics and treatment outcomes.Develop innovative solutions to complex engineering and manufacturing production problems through identification and implementation of advanced manufacturing processes.Prototyping and Experimentation:Develop and test prototypes for orthodontic brackets, wires, and aligners.Collaborate with orthodontists and dental professionals to validate designs and optimize manufacturing processes.Process Design and Improvement:Design, develop, test, and evaluate integrated systems for managing industrial production processes.Implement lean manufacturing principles and practices to improve efficiency and eliminate waste in the manufacturing process.Automation and Digital Workflow:Develop and implement automated systems for orthodontic manufacturing processes.Evaluate current processes and workflows to identify areas where automation could improve throughput and reduce operational risk.Leverage automation tools to streamline manufacturing processes.Implement digital workflows for efficient production.Material Science and Biocompatibility:Understand material properties (e.g., stainless steel, titanium, ceramic) and their suitability for orthodontic applications.Ensure biocompatibility and safety of materials used in orthodontic devices.Quality Control and Regulatory Compliance:Establish quality control protocols for manufacturing orthodontic products.Adhere to industry standards and regulatory requirements (e.g., FDA guidelines).Collaboration and Cross-Functional Teams:Work closely with dental professionals, product designers, and manufacturing teams.Translate clinical insights into practical manufacturing solutions.Continuous Learning and Innovation:Stay informed about advancements in orthodontic technology.Explore novel approaches to enhance patient comfort, treatment efficiency, and aesthetics.Specialized Manufacturing Techniques (preferred):Experience with
MIM (Metal Injection Molding) ,
wire drawing ,
wire forming , and
elastics
manufacturing techniques.Knowledge of
Ti (Titanium) coating ,
Nitinol , and
CuNiTi (Copper Nickel Titanium)
manufacturing processes.Ability to apply these specialized techniques to the development and production of orthodontic devices.Experience with Specific Technologies:Proficiency in working with
Fanuc
robotics,
Cognex
vision systems, and
Keyence
measurement systems.Experience with
laser
technology in manufacturing processes, including laser cutting, welding, and marking.Job Requirements:Bachelor’s degree in Mechanical, Industrial, Biomedical engineering, Materials science, or a related field; Master's degree is a plus.10+ years of experience in orthodontic manufacturing and/or automation with a focus on machine development and production release.3+ years’ experience working in medical devices with familiarity of FDA requirements or another regulated (EU MDR, Canada, etc.).Proven experience with lean manufacturing principles and tools such as 5S, Kaizen, and Value Stream Mapping.Proficiency in CAD software (e.g., SolidWorks, AutoCAD) for design and modeling.Experience with robotics and other advanced manufacturing technologies.Knowledge of finite element analysis (FEA) for structural simulations.Strong problem-solving abilities and attention to detail.Strong communication and teamwork skills.Experience with additive manufacturing (3D printing) techniques preferred.
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As a
Senior R&D Process Development Engineer
specializing in orthodontic dental manufacturing, you will be leading the innovation, contributing to the development of cutting-edge products that enhance oral health. Your expertise will play a crucial role in improving existing processes, creating novel solutions for orthodontic devices, and overseeing the development and release of advanced manufacturing machinery to production. This is a hybrid position and requires someone in the office 3 days per week.Leadership Responsibilities:Lead
and
mentor
a team of engineers and technicians.Drive
the execution of projects and manage resources to ensure goals are met on time and within budget.Foster
a culture of continuous improvement and innovation.Communicate
effectively with all levels of the organization, from entry-level employees to senior executives.Collaborate
with cross-functional teams to align on strategy and implementation.Technical Responsibilities:Machine Development and Production Release:Lead the design, development, and implementation of advanced manufacturing machinery.Oversee the transition of machinery from development to production, ensuring smooth integration into existing processes.Collaborate with cross-functional teams to troubleshoot and resolve machinery and production issues.Ensure machinery meets all safety, quality, and efficiency standards before release to production.Research and Analysis:Conduct thorough research specific to orthodontic materials, manufacturing techniques, and patient needs.Analyze data related to dental biomechanics and treatment outcomes.Develop innovative solutions to complex engineering and manufacturing production problems through identification and implementation of advanced manufacturing processes.Prototyping and Experimentation:Develop and test prototypes for orthodontic brackets, wires, and aligners.Collaborate with orthodontists and dental professionals to validate designs and optimize manufacturing processes.Process Design and Improvement:Design, develop, test, and evaluate integrated systems for managing industrial production processes.Implement lean manufacturing principles and practices to improve efficiency and eliminate waste in the manufacturing process.Automation and Digital Workflow:Develop and implement automated systems for orthodontic manufacturing processes.Evaluate current processes and workflows to identify areas where automation could improve throughput and reduce operational risk.Leverage automation tools to streamline manufacturing processes.Implement digital workflows for efficient production.Material Science and Biocompatibility:Understand material properties (e.g., stainless steel, titanium, ceramic) and their suitability for orthodontic applications.Ensure biocompatibility and safety of materials used in orthodontic devices.Quality Control and Regulatory Compliance:Establish quality control protocols for manufacturing orthodontic products.Adhere to industry standards and regulatory requirements (e.g., FDA guidelines).Collaboration and Cross-Functional Teams:Work closely with dental professionals, product designers, and manufacturing teams.Translate clinical insights into practical manufacturing solutions.Continuous Learning and Innovation:Stay informed about advancements in orthodontic technology.Explore novel approaches to enhance patient comfort, treatment efficiency, and aesthetics.Specialized Manufacturing Techniques (preferred):Experience with
MIM (Metal Injection Molding) ,
wire drawing ,
wire forming , and
elastics
manufacturing techniques.Knowledge of
Ti (Titanium) coating ,
Nitinol , and
CuNiTi (Copper Nickel Titanium)
manufacturing processes.Ability to apply these specialized techniques to the development and production of orthodontic devices.Experience with Specific Technologies:Proficiency in working with
Fanuc
robotics,
Cognex
vision systems, and
Keyence
measurement systems.Experience with
laser
technology in manufacturing processes, including laser cutting, welding, and marking.Job Requirements:Bachelor’s degree in Mechanical, Industrial, Biomedical engineering, Materials science, or a related field; Master's degree is a plus.10+ years of experience in orthodontic manufacturing and/or automation with a focus on machine development and production release.3+ years’ experience working in medical devices with familiarity of FDA requirements or another regulated (EU MDR, Canada, etc.).Proven experience with lean manufacturing principles and tools such as 5S, Kaizen, and Value Stream Mapping.Proficiency in CAD software (e.g., SolidWorks, AutoCAD) for design and modeling.Experience with robotics and other advanced manufacturing technologies.Knowledge of finite element analysis (FEA) for structural simulations.Strong problem-solving abilities and attention to detail.Strong communication and teamwork skills.Experience with additive manufacturing (3D printing) techniques preferred.
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