Job Information
Ricoh Americas Corporation Biomedical Engineer II in Exton, Pennsylvania
Engineer II, Biomedical. Additive Manufacturing
POSITION PROFILE
The Engineer II, Biomedical. Additive Manufacturing is a position combining Project, Process, and Design Engineering skills. The primary responsibility is to create, implement and verify/validate processes of a 3D Printing lab for acquisition of customer 3D images, perform 3D model refinement or modifications based on the customer's use case, obtain validation and approvals of changes, and produce a final part file for printing. Support production scheduling and quality inspection of the parts to ensure the final output adheres to the stated quality tolerances.
JOB DUTIES AND RESPONSIBILITIES
Segmentation of DICOM datasets such as CT and MRI to produce patient-specific anatomic models, surgical guides, implants, etc.
Reviews incoming CAD files for production via print queue and release for fabrication.
Prepares files for printing including orientation, support generation, nesting, and tool paths, as examples.
Implements and utilizes equipment and software tools including 3D Printers, 3D CAD software and other additive manufacturing machines and related devices as needed.
Produces customer-designed products through proficiency in CAD and in the use of 3D print equipment.
Completes quality reports and other paperwork as necessary.
Provide production support to AM operation team (technicians and production lead) manufacturing, finishing, quality check, packaging, shipping, billing, and customer support as required.
Provides input for the production control activities for the manufacturing operation. Participates in process validation IQ/OQ/PQ activities over the service life of capital equipment assets.
Collaborate to develop production schedules and ongoing analyses to maximize print performance and quality.
Complies with all regulatory and production requirements.
Monitors usage through procedures, logs, and other administrative tools.
Achieves customer satisfaction by finishing projects accurately in a timely manner.
Supports continuous improvement and client-focused culture within the engineering environment, by actively gathering post-market customer feedback information and incorporating this data into improvements to QMS processes.
Supports the Quality Control function to ensure effective execution of all quality assurance processes and standards.
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.
Supports expansion of site capabilities through addition of both new engineering staff training and model utilization opportunities for customers.
Continually seeks to advance Ricoh's AM production systems and standards.
Encourages and builds positive relationships, communicating effectively with all co-workers and vendors.
Support systems development including prototyping, integration, testing, design transfer and product launch.
Participates in all aspects of the design process, including developing design specifications, mitigating product risks, and building the engineering design history file.
Build simulations and models of product functions and expected performance to conduct robust feasibility studies.
Write and execute engineering test strategies to perform successful product verification and validation of medical device products.
Participates in development risk assessments and compliant options to support mitigation.
Supports the preparation of additional data/information requested by regulatory department and drafts internal responses to all such requests.
Provide technical assessment, consultation, and opinion for medical devices development issues and impact of any planned changes to products.
Participates in the development, review, and release of product documents
Performs other duties as assigned.
Additional Pay Details
Compensation Range
$67,000 - $ 80,000
QUALIFICATIONS (Education, Experience, and Certifications)
Bachelor's degree Biomedical engineering strongly preferred or equivalent experience in medical 3D printing/additive manufacturing; degree or certificate in 3D printing related field; industry-specific certifications are desirable.
Experience in an Additive or 3D environment is required.
Experience with CAD is required, including demonstrated ability to modify existing CAD files.
Experience working in a QMS or FDA regulated environment strongly preferred.
Familiarity with production standards is preferred such as ISO 9000, ISO 14971, ISO 13485, and 21CFR.
Experience with standard business software.
Background in human anatomy/biology or radiology strongly preferred.
Experience in the segmentation of DICOM datasets such as CT and MRI required.
Prior experience with customer service strongly preferred.
KNOWLEDGE, SKILLS AND ABILITIES
Understanding of human anatomy, clinical/surgical procedures
Knowledge of principles of image acquisition, translation, verification, and validation of image acquisition processes for use with 3D printing
Engineering design knowledge of materials selection, simulation and modeling, process optimization, gathering, translating and developing customer requirements.
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.
Ability to work with a variety of 3D printing and 3D CAD technologies.
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 grinding/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
Willingness to confidently adapt to a changing work environment, circumstances, and duties, despite stressful situations.
Remains updated on current technology and trends in the industry.
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.
Builds and manages relationships within the facility to acquire resources.
Is well organized and uses time effectively.
Ability to work in a high-performance culture with clear expectations of performance.
Analyzes and presents any given subject in a clear, concise, and logical manner both orally and written. Interacts effectively with different audiences (e.g. internal management, external clients). Excellent presentation skills.
MUST BE ABLE TO MULTI-TASK
MUST BE SELF-MOTIVATED
MUST BE ENTHUSIASTIC
MUST HAVE STRONG WORK ETHIC
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:
Choose from a broad selection of medical, dental, life, and disability insurance options.
Contribute to your financial security with Retirement Savings Plan (401K), Health Savings Account (HSA), and Flexible Spending Account (FSA) investments.
Augment your education with team member tuition assistance programs.
Enjoy paid vacation time and paid holidays annually
Tap into many other benefits to enhance your health, wellness, and ongoing personal and professional development.
EEO/Affirmative Action Employer -- M/F/Disability/Veteran