R&D Engineer II

Responsibilities

• Contribute to the development and launch of new drug/medical device combination products.
• Independently design, execute, and interpret novel engineering research and development.
• Generate and lead new engineering proposals. Investigate, identify, develop, and optimize new test methods and techniques and set and meet experimental timelines. Innovate and implement new experimental protocols.
• Act as a critical contributor to feasibility, development, and verification testing stages of product development through creation and release of new test methods, as well as design verification plans, protocols, records, and reports.
• Effectively organize and present scientific plans and data. Contribute to writing and conceptual framework of publications, presentations, and patents.
• Act as a resource or mentor for others.

Qualifications

• Required: Must possess a Master’s Degree in Industrial and Systems Engineering, Mechanical Engineering, Biomedical Engineering, or a related field, and 1 year of experience in the job offered or in a regulated device engineering or validation-related occupation.
• Required: 1 year of experience involving the following: Regulated device testing processes, including detailed verification and validation methodologies.
• Required: Design control, risk management, and regulatory standards including ISO, FDA and ASTM standards.
• Required: Developing, managing, and maintaining complex technical drawings and designs, utilizing SolidWorks or a similar 3D CAD design software.
• Required: Demonstrated problem-solving skills for effectively identifying, analyzing, and resolving technical issues to ensure project success and product quality.
• Required: Quality assurance processes for ensuring comprehensive compliance and maintenance of high standards throughout development and testing.
• Required: Advanced data analytics for conducting analyses and deriving actionable insights for informed decision making.
• Required: Project management.

Education

• Master’s Degree in Industrial and Systems Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.