Senior Product Development Engineer- Catheters

Join our early-stage start-up medical device client, which is developing innovative cardiovascular intervention technology, as their founding Product Development Engineer. Our client’s focus centers on delivering breakthrough therapeutic approaches for patients facing complex cardiac challenges through advanced device engineering and evidence-based clinical development.

The Product Development Engineer will bring comprehensive practical experience in therapeutic device development and will be involved in advancing from initial ideation through regulatory clearance and commercialization. This individual will spearhead prototype creation, laboratory validation, and iterative design refinement of advanced catheter technologies.

The position requires on-site presence in Washington DC, during the initial six to twelve-month period, subsequently moving into a hybrid arrangement combining reduced on-site requirements with remote work flexibility as the program advances.

Responsibilities of the Product Development Engineer:

• Direct the conceptualization, prototype development, and evolutionary refinement of catheter-based platforms for cardiovascular intervention procedures.
• Transform clinician and research partner insights into tangible design enhancements.
• Create and optimize functional prototypes utilizing accelerated prototyping methodologies, precision machining, and catheter fabrication processes.
• Conduct laboratory, pre-clinical, and verification studies to guide design decision-making.
• Partner with research scientists, practicing physicians, and interdisciplinary startup team members.
• Maintain comprehensive design documentation, experimental outcomes, and quality system records aligned with regulatory standards.
• Facilitate progression from prototype phase to manufacturing scale-up and commercial readiness.