Biomedical Engineer jobs in Florida

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