Surf Search
Senior Product Development Engineer - Catheters
Surf Search, Washington, District of Columbia, us, 20022
Overview
Biotech Recruiter | Medical Device & Medtech Recruiter | Pharmaceutical Recruiter | Healthcare Recruiter | Chemical Recruiter 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
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
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. Occupational Code: 17-2141.00 (Mechanical Engineers) Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering, Product Management, and Quality Assurance Industries: Medical Equipment Manufacturing Arlington, VA $130,000.00-$155,000.00 Bethesda, MD $115,000.00-$130,000.00 Columbia, MD $75,000.00-$95,000.00 Bethesda, MD $90,000.00-$110,000.00 Laurel, MD $49,996.80-$290,004.00 Laurel, MD $49,996.80-$290,004.00 Columbia, MD $80,000.00-$95,000.00 Washington DC-Baltimore Area $88,100.00-$134,400.00 Germantown, MD $80,000.00-$95,000.00 Germantown, MD $75,000.00-$90,000.00 Gaithersburg, MD $88,100.00-$134,400.00 Washington, DC $150.00-$240.00 Arlington, VA $68,000.00-$85,000.00 #J-18808-Ljbffr
Biotech Recruiter | Medical Device & Medtech Recruiter | Pharmaceutical Recruiter | Healthcare Recruiter | Chemical Recruiter 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
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
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. Occupational Code: 17-2141.00 (Mechanical Engineers) Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering, Product Management, and Quality Assurance Industries: Medical Equipment Manufacturing Arlington, VA $130,000.00-$155,000.00 Bethesda, MD $115,000.00-$130,000.00 Columbia, MD $75,000.00-$95,000.00 Bethesda, MD $90,000.00-$110,000.00 Laurel, MD $49,996.80-$290,004.00 Laurel, MD $49,996.80-$290,004.00 Columbia, MD $80,000.00-$95,000.00 Washington DC-Baltimore Area $88,100.00-$134,400.00 Germantown, MD $80,000.00-$95,000.00 Germantown, MD $75,000.00-$90,000.00 Gaithersburg, MD $88,100.00-$134,400.00 Washington, DC $150.00-$240.00 Arlington, VA $68,000.00-$85,000.00 #J-18808-Ljbffr