Senior Engineer, Clinical

 

POSITION PROFILE

The Senior Engineer, Clinical is a position which interacts with physician customers, biomedical engineers, and the clinical applications team in the fulfillment of 3D printed patient-specific applications. The primary responsibilities are to operate a point-of-care 3D printing lab from DICOM segmentation, STL file optimization, 3D printing, quality assurance, delivery of the 3D printed model to the end-user, and act as a champion to expand the use of the print lab.

 

Job Duties and Responsibilities

Segmentation of DICOM datasets such as CT and MRI to produce patient-specific anatomic models, bolus, surgical guides, implants, etc. Prepares files for printing including orientation and support generation. Collaborates with biomedical engineering and clinical applications teams to ensure efficient and effective outcomes in fulfilling physician customer orders. Utilizes and maintains equipment and software tools including 3D Printers, 3D CAD software and other additive manufacturing machines and related devices as needed. Performs daily production workflow processes, including manufacturing, finishing, quality check, packaging, and shipping. Maximizes print performance and quality through effective use of job scheduling practices and software. Maintains optimal device performance through preventative maintenance and repairs, as well as calibration of equipment. Performs shipping and receiving functions for the receipt and storage of materials for processing, and the distribution of finished goods. Tracks inventory of equipment consumables in accordance with company guidelines and processes. Coordinates with third party/OEM external repair services partners or Ricoh service personnel. Maintain up-to-date records and documentation. Develop and maintain relationships with coworkers, external vendors, and partners to ensure successful program operations. Achieves customer satisfaction by finishing projects accurately in a timely manner. Adds new customer accounts and supports customer onboarding to the Ricoh 3D case management Portal. Completes quality reports and other paperwork as necessary. Complies with all regulatory and production requirements and escalates any quality / compliance concerns with urgency and promotes a culture of continuous improvement within all areas of the site. Monitors usage through procedures, logs, and other administrative tools.  Supports expansion of site capabilities through model utilization opportunities for customers.  Contributes to the investigation of production problems and product quality issues, collaborates with other functional areas to identify root cause. Identifies, segregates, evaluates, and dispositions nonconforming products with guidance from Quality team. Perform daily product inspections per defined workflows, including incoming, in-process and final QC inspections. Maintains records/reports of the completed inspections. Ensures effective execution of all quality assurance processes and standards. Supports the preparation of additional data/information requested by regulatory department and drafts internal responses to all such requests. Supports Sales efforts through networking within the hospital system, tours, and activities such as lunch and learns with medical personnel. Performs other duties as assigned.

 

QUALIFICATIONS (Education, Experience, and Certifications)

Requires Bachelor's degree Mechanical or Biomedical engineering preferred or equivalent experience within Medical AM industry; degree or certificate in 3D printing related field strongly preferred; industry-specific certifications are desirable 1-3 years' experience working with polymer 3D printers, strongly preferred. Prior experience with 3D scanners and 3D scanning software is a plus. Experience with CAD is required, including demonstrated ability to modify existing CAD files. Experience working in a QMS or FDA regulated environment preferred. Previous experience with industry standard workflow and automation systems is 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. Requires experience in the segmentation of DICOM datasets such as CT and MRI. Prior experience with customer service strongly preferred. Prior experience in packaging & shipping operations a plus.

 

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. Must work well independently. The successful candidate will be project oriented with the ability to stay on task, but with considerable variety between tasks. Ability to handle, clean, and polish both robust and delicate 3D printed parts. 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. Willingness to confidently adapt to a changing work environment, circumstances, and duties, despite stressful situations. Highly motivated; can handle multiple assignments and operate effectively. 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

 

Working Conditions, MENTAL AND PHYSICAL DEMANDS

Work is performed in multiple types of environments including typical office and manufacturing. Requires careful handling of delicate parts. Requires regular communication with teams such as biomedical engineering, clinical applications, quality, production, and the customer. Minor physical effort is required, which may involve long periods of sitting, standing, walking or similar activities. Requires moderate dexterity - regular application of basic skills (calculator, keyboard, etc.). Overtime and/or on-call schedules may be required to complete tasks on time. Occasional business travel may be required.

 

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job.