Senior Catheter Development Engineer

This position is responsible for leading design, manufacturing process development, sustaining engineering, and completion of complex product development deliverables for catheter-based medical devices supporting client companies and internal projects.

The role emphasizes independent ownership of catheter design, hands‑on process development, optimization, advanced problem solving, and production support from prototype through early‑stage and ongoing manufacturing. This position also includes hands‑on collaboration with manufacturing personnel, with a strong focus on technician training, process standardization, and execution on the manufacturing floor.

• Completes detailed CAD designs and specification drawings (advanced level proficiency)
• Drafts and owns manufacturing work instructions and drives continuous improvement over time
• Develops robust, scalable catheter assembly and inspection processes, including:
  • Reinforcement (braiding, coiling, laser‑cut hypo tube)
  • Tipping, bonding, and thermal forming
• Leads process development activities from concept through manufacturing transfer
• Optimizes manufacturing processes using advanced process controls and statistical methods
• Completes Statistical Tolerance Analysis and process capability assessments
• Leads Process Failure Mode and Effects Analysis (PFMEA) and contributes to Risk Management strategy
• Maintains detailed engineering and build records
• Completes documentation in support of project tasks and deliverables
• Coordinates with outside suppliers to ensure delivery of materials and services
• Acts as a technical lead within project teams and supports project planning activities
• Actively participates in collaborative project team activities (meetings, reviews, presentations)
• Leads or co‑leads Design Reviews and provides authoritative technical direction
• Interfaces directly with customers to communicate technical progress, risks, and solutions
• Provides hands‑on training and cross‑training to manufacturing technicians to ensure consistent process execution
• Develops training materials, work instructions, and visual aids to support technician proficiency and process standardization
• Acts as a technical resource on the manufacturing floor to support builds, troubleshoot processes, and ensure adherence to defined methods
• Leads and supports initial builds, engineering runs, and pilot production activities alongside technicians
• Identifies process variability during builds and implements real‑time corrections and improvements

• Bachelor’s Degree in Engineering or Technical Field
• 6–10 years of experience in a Technical or Process Engineering role (medical device).
• Hands‑on experience in catheter manufacturing processes required, including multiple of the following:
  • Extrusion
  • Reflow/lamination
  • Braiding and/or coiling
  • Tipping and thermal forming
  • Adhesive bonding and small‑component assembly
• Proficiency in Solid Works (advanced level)
• Strong working knowledge of statistical methods and process optimization
• Experience working in regulated environments (FDA QSR and ISO 13485)
• Strong mechanical aptitude with hands‑on problem‑solving ability
• Detail‑oriented with strong documentation practices
• Experience training or supporting manufacturing technicians in catheter assembly processes
• Customer focus with strong technical communication and presentation skills

• Creativity and innovation for product and process development solutions
• Concept translation into manufacturable processes
• Analytical skill and structured problem solving (advanced level)
• Mechanical design and fixture development
• Solid Works part, assembly, and drawing skills (advanced level)
• Manufacturing process knowledge (deep expertise in catheter technologies)
• Materials knowledge (polymers, metals, adhesives)

• Design for manufacturability / assembly / reliability
• Cross-functional collaboration across engineering, quality, and operations
• Customer-facing communication and technical discussions
• Technical decision-making and risk-based problem solving
• Driving process adoption and consistency through technician training and engagement

$115,000 to $160,000;
Bonus eligible depending on achieving company performance targets, 5% basis

This position will be eligible to enroll in benefits including health, dental and vision programs as well as AD&D and Long-Term Disability Insurance, 401(k). Position will accrue 15 PTO days per year and 1 additional day for each year of service (up to 25 days).