Ricoh USA, Inc

The Additive Manufacturing Engineer plays a key role in the Ricoh 3D for Healthcare team's goal of onboarding customers through the intake of projects including both partner production and patient specific models, which may include the interpretation of 3D models and CAD drawings, process translation and development, equipment validation, and material resourcing and characterization.. The Additive Manufacturing Engineer translates the technical needs of the customer to the production team, develops new and advances existing infrastructure to additively manufacture new products.. Responsible for leading projects and actions that result in improved quality, process stability, and reduced cost, as well as meeting customer requirements for the manufacturing of additive manufacturing products, from receiving raw material to the shipping of finished goods. Execute continuous improvement activities which focus on improved quality and efficiencies, increased production output, waste elimination, handling damage prevention, and non-conformance elimination, ultimately driving cost reduction and reporting. BS in Engineering, with prior experience in medical 3D printing/additive manufacturing strongly preferred

additive manufacturing

Come Create at Ricoh If you are seeking a team driven by passion and purpose, come create with us at Ricoh. We are a team of information seekers and customer-obsessed collaborators who aspire to deliver the services, solutions, and technologies that empower business success. We are looking for talented, inspired individuals to join us to help drive high-performance team and our commitment to excellence. Ricoh is an integrated solutions provider and partner that connects people and technology, creates outstanding customer experiences, and delivers innovation for businesses worldwide. We empower digital workplaces by enabling individuals to work smarter from any location and harness the power of information-how it is collected, stored, managed, and shared-to unlock the potential in every organization. We deliver services and technologies that inspire our customers' success and guide them toward a better and more sustainable future. If you are seeking a purpose-driven and passionate team, come create with us, and help drive our high-performance culture of excellence into tomorrow. Invest in yourself At Ricoh, you can: <ul><li> Choose from a broad selection of medical, dental, life, and disability insurance options. </li><li> Contribute to your financial security with Retirement Savings Plan (401K), Health Savings Account (HSA), and Flexible Spending Account (FSA) investments. </li><li> Augment your education with team member tuition assistance programs. </li><li> Enjoy paid vacation time and paid holidays annually. </li><li> Tap into many other benefits to enhance your health, wellness, and ongoing personal and professional development. </li></ul> POSITION PROFILE The Additive Manufacturing Engineer plays a key role in the Ricoh 3D for Healthcare team's goal of onboarding customers through the intake of projects including both partner production and patient specific models, which may include the interpretation of 3D models and CAD drawings, process translation and development, equipment validation, and material resourcing and characterization. The Additive Manufacturing Engineer translates the technical needs of the customer to the production team, develops new and advances existing infrastructure to additively manufacture new products. JOB DUTIES AND RESPONSIBILITIES Work with customers, engineering, and production teams to intake production orders, review those orders for manufacturability, and process them into the production team. . Support intake and implementation of production work. This includes review and development of customer requirements, leading prototyping efforts, process development, writing of process documents, and transfer to production. . Responsible for leading projects and actions that result in improved quality, process stability, and reduced cost, as well as meeting customer requirements for the manufacturing of additive manufacturing products, from receiving raw material to the shipping of finished goods. . Develop knowledge base and understanding for in-situ (live) monitoring of AM machine builds. . Analyze, collaborate and understand additive manufacturing build failure events to implement countermeasures for future builds. . Will develop, lead, and perform new and existing product and process validations, while also supporting new product First Article Inspection. . Setup AM build job and run AM machines correctly and clearly document information. . Writing SOP and Work Instructions for incoming contract manufacturing . This role will also support the development and ongoing compliance with internal systems and procedures to meet ASTM, ISO 13485, FDA, and other required regulatory and product standards for the manufacturing of medical device products. . Subject Matter Expert for assigned processes and support customer, ISO, FDA, and internal audits. . Work with engineers and production operators in process development such as design and fabrication of jigs, tools, fixtures, gages, and special equipment. . Execute continuous improvement activities which focus on improved quality and efficiencies, increased production output, waste elimination, handling damage prevention, and non-conformance elimination, ultimately driving cost reduction and reporting. . Participate in new product pre-production meetings to ensure processes are available for product specific projects. . Working with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new process/product development. . Support development, implementation, and management of PFMEAs and risk mitigation into the quality and manufacturing process. . Responsibilities may include some or all of the following: project management, process development, process print development, development of work instructions, and operator training on manufacturing processes. . Responsible for working with Quality Engineering to develop quality plans and ensure compliance with Good Manufacturing Practices . Operate different types of equipment such as 3D printers, alkaline baths, pressure blasters, ultraviolet light chambers, 3D scanners, finishing equipment, etc. . Leads, supports, or participates in the Material Review Board (MRB) for internal non-conformances and customer returns. . Supports the development of inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions. . Supports design projects for both internal and external customers . Support prototyping, machining, as well as development and testing of design projects, ensuring smooth transition to full-scale production. . Write protocols, execute, analyze test data, and generate reports (eg FEA, tolerance analysis, testing, etc.) to verify or validate that designs meet functional and performance specifications, including interactions with outside testing facilities. . Contributes to the investigation of production problems and product quality issues, collaborates with other functional areas to identify root cause, and recommend corrective action/countermeasure, prepares action plan, manages solution implementation, and summarizes and reports results, updating the risk management files with new risk mitigation solutions. . Assists with resolution of issues concerning pricing, orders-in and invoicing by interacting with Sales. . Encourages and builds positive relationships, communicating effectively with all co-workers and vendors. . Supports the preparation of additional data/information requested by regulatory department and drafts internal responses to all such requests, i.e., FDA 510K submissions. . Performs other duties as assigned. Requirements: QUALIFICATIONS (Education, Experience, and Certifications) .BS in Engineering, with prior experience in medical 3D printing/additive manufacturing strongly preferred . Equivalent experience will be considered. . Degree or certificate in 3D printing related field; industry-specific certifications are desirable. . Experience in a QMS or FDA regulated environment producing medical devices required, 2 – 4 years. . Experience using 3D CAD packages and AM-related software required. . Experience in managing contract manufacturing projects preferred. . Familiarity with design for additive manufacturing and production standards is preferred such as ASTM, ISO 9000, ISO 14971, ISO 13485, and 21CFR. . Experience with standard business software. . Prior experience with customer service strongly preferred Has a strong sense of ownership. . Self-motivated, hands-on, with a practical mindset, and capable of setting and reaching ambitious goals. . Team player with excellent communication skills with the ability to present information and respond to questions from groups of peers, managers, customers, regulatory agencies, and sales representatives. . Engineering design knowledge of materials selection, simulation and modeling, process optimization, gathering, translating, and developing customer requirements in functional mechanical solutions. . Understanding of additive manufacturing processes and design for additive manufacturing. . Excellent verbal and written communication skills and ability to understand technical documentation. . Excellent customer service skills with the ability to guide customers and develop and maintain strong customer relationships by responding promptly to clients' needs. Provides follow-up communication to ensure client satisfaction. . Competency in the identification and investigation of issues, determination of appropriate solutions, and implementation to resolve the problem. . Ability to work with a variety of post processing technologies and products such as Vapor (IPA, acetone, etc.) finishing/smoothing, support removal, general part cleanup using hand tools, familiarity w/ basic GD&T (geometric dimensioning & tolerancing) tools, vibratory/ultrasonic cleaning, and rinding/sanding. . Ability to execute activities aligned to project plans. . Ability to evaluate workflows and develop improvement strategies. . The successful candidate will be project oriented with the ability to stay on task, but with considerable variety between tasks, while contributing to building a positive team environment . Leads, supports, or participates in the Material Review Board (MRB) for internal non-conformances and customer returns. . Supports the development of inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions. . Supports design projects for both internal and external customers . Support prototyping, machining, as well as development and testing of design projects, ensuring smooth transition to full-scale production. . Write protocols, execute, analyze test data, and generate reports (eg FEA, tolerance analysis, testing, etc.). to verify or validate that designs meet functional and performance specifications, including interactions with outside testing facilities. . Contributes to the investigation of production problems and product quality issues, collaborates with other functional areas to identify root cause, and recommend corrective action/countermeasure, prepares action plan, manages solution implementation, and summarizes and reports results, updating the risk management files with new risk mitigation solutions. . Assists with resolution of issues concerning pricing, orders-in and invoicing by interacting with Sales. . Encourages and builds positive relationships, communicating effectively with all co-workers and vendors. . Supports the preparation of additional data/information requested by regulatory department and drafts internal responses to all such requests, i.e., FDA 510K submissions. . Performs other duties as assigned. . Willingness to confidently adapt to a changing work environment, circumstances, and duties, despite stressful situations. . Highly motivated; can handle multiple assignments and operate effectively in production environment. . Strong problem-solving skills needed to resolve complex process, scheduling, and quality problems for which an established method is not clear or may not exist. . Is well organized and uses time effectively. . Ability to work in a high-performance culture with clear expectations of performance. . MUST BE ABLE TO MULTI-TASK . MUST BE SELF-MOTIVATED . MUST BE ENTHUSIASTIC . MUST HAVE STRONG WORK ETHIC Ricoh is an EEO/Affirmative Action Employer - Minorities/Women/Protected Veterans/Disabled.

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