R&D Engineer III

About the Role

Develops new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.

Responsibilities

• Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes, or equipment.
• Completes complex engineering work in one or more of the following: technology development, product design and development, testing of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Selects techniques to solve complex problems and make sound design recommendations.
• Summarizes, analyzes, and draws conclusions from complex test results. Designs and prepares complex reports to communicate results to the technical community.
• Designs and coordinates complex engineering tests and experiments.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices.
• Translates customer needs into product requirements and design specifications.
• Responsible for engineering documentation.
• Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
• May train and/or provide work direction to technicians and entry-level engineers.
• Demonstrates PDP/TPD system knowledge through delivery of high-quality and high-impact deliverables.

Quality Systems Duties and Responsibilities

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Handles CAPAs/NCEPs/SCAR investigations as needed, initiating and managing design changes, etc.

Requirements

• 5–8 years of experience with a BS, 3–6 years with an MS, or 0–3 years with a PhD.
• Experience with engineering prints and driving design changes in medical devices is required.
• Background in mechanical engineering.
• Ability to take work direction and work independently.
• Desire at least 5–8 years of medical device experience.

Additional Information

Primary work assignments will involve supporting the manufacturing line for the hepatic artery infusion pump and accessories—updating engineering prints as necessary, communicating with the contract manufacturer and client operations/design teams.