Research And Development Engineer

Work Authorization

Must be authorized to work in the U.S. (no sponsorship available)

The R&D Engineer independently conducts development work as part of major research and/or new product development (NPD) projects. This role receives minimal technical direction on complex assignments and is viewed as an expert in one or more in‑house technologies. The engineer will contribute significantly to the design and development of a new large‑bore delivery catheter and associated regulatory deliverables.

• Collaborate with a small team of new product design engineers on the development of a new large‑bore delivery catheter.
• Independently develop key deliverables required for a 510(k) regulatory submission, including:
• Detailed print packages
• Specification generation and rationale
• Mapping specifications to essential design outputs
• DFMEAs
• Tolerance analyses
• Device material assessments
• Bill of materials

• Provide guidance to product and technology teams.
• Assess feasibility and soundness of alternative engineering processes, products, or equipment.
• Coach others on engineering documentation and best practices.
• Demonstrate strong PDP/TPD system knowledge through high‑quality, high‑impact deliverables.

• Coordinate, manage, and document project goals and progress.
• Recommend revisions to project plans as needed.
• Work effectively in a mixed onsite + remote environment.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline.
• 5+ years of experience in design assurance, new product development, or related medical device/regulated industry roles.
• Strong experience with design controls, print packages, tolerance analysis, and GD&T.
• Demonstrated ability to create detailed technical documentation.
• Self‑motivated with strong problem‑solving skills and a bias for action.
• Excellent verbal and written communication skills.
• Demonstrated use of quality tools and methodologies.

• Experience with medical devices such as catheters or delivery systems.
• Quality Integration experience.
• 510(k) regulatory experience.
• Understanding of ISO 13485, ISO 14971, and Quality System Regulations, especially Design Controls and Risk Analysis.
• Strong problem‑solving skills and ability to facilitate structured problem‑solving processes.
• Experience with design changes, complaint reduction, and corrective actions.
• Adaptable collaborator in both team‑based and self‑directed work environments.