This role is responsible for supporting the engineering activities of Ra Medical’s DABRA catheters. These activities may include design, research, verification activities, validation activities, specification refinement, process characterization, protocols, reports, risk documentation, equipment/tooling/fixturing design and documentation, inspection and test requirements, and all supporting documentation per Ra Medical’s product development process.
DUTIES AND RESPONSIBILITIES:
- Product Development: Under direction from more senior staff, design, develop, test and refine cost-effective device prototypes to enable in vitro and in vivo testing. Conduct studies to demonstrate feasibility of a product concept. Develop processes necessary to fabricate devices. Develop and implement test methods for assessing the quality of in-process and finished products. Develop, execute and analyze design verification and validation studies.
- Project Management / Participation: Work with other Engineering and cross-functional employees to achieve company and department milestones on time and on budget. Maintain flexibility in a highly dynamic environment working with highly dedicated cross-functional colleagues in a culture focused on continuous improvement.
- Manufacturing Support: Implement improvements to manufacturing processes and process flow. Develop fixturing or other tools necessary for efficient manufacturing operations. Conduct equipment preventative maintenance or qualification studies as necessary. Conduct preclinical build operations as necessary. Support process validation activities.
- Quality Support: Write, amend and review SOP’s, batch records, raw material specifications, drawings and other documentation as required to support product manufacturing and quality control testing. Support resolution of non-conforming material or corrective actions (CAPAs).
- Engineering / Scientific Acumen: Generate and present scientific data, including scientific papers and research reports.
- Documentation: Throughout the course of all job activities, maintain accurate records and documentation as prescribed in the Quality System Regulation (QSR) established by the FDA (21 CFR Part 820)
- Bachelor’s Degree (BS) in Mechanical Engineering, Electrical Engineering, or other technical degree from four-year college or university, or 5+ years of related experience and/or training, or equivalent combination of education and experience.
- Computer skills required: Microsoft Office
- Other preferred skills: Catheter Design, SolidWorks, Minitab, OrCAD, Failure analysis, Lean Six Sigma, Machining experience, Lab view, Statistics, Technical communications, Project management, Mechatronics engineering