Senior Product Development Engineer - Catheters

Job Description

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.

Requirements of the Product Development Engineer :

• Undergraduate or graduate degree in Bioengineering, Mechanical Engineering, or comparable discipline.
• Minimum five years of direct experience in catheter-based.
• Demonstrated history of contributing to products that progressed from initial concept to commercial availability (preferably moderate to high-risk device classifications).
• Specialized knowledge in catheter engineering, prototype fabrication, bonding methodologies, braiding techniques, extrusion processes, and assembly procedures.
• Proficiency with catheter construction materials (including but not limited to Pebax, PTFE, braided reinforcement structures, inflation components).
• Exceptional laboratory capabilities and capacity for rapid design iteration and problem resolution.
• Understanding of design control frameworks, ISO 13485 standards, and FDA regulatory landscape preferred.
• Entrepreneurial approach, adaptability within resource-constrained startup environments, and flexibility to embrace changing role requirements.

Responsibilities of the Product Development Engineer :

Occupational Code : 17-2141.00 (Mechanical Engineers)