We are seeking an experienced Catheter Engineer to own the design, development, and regulatory approval of a broad range of catheter-based medical devices. This is a high-impact, hands-on role for a technically deep engineer who thrives at the intersection of product development, regulatory strategy, and cross-functional project leadership.
What You'll Do:
Design & Development- Lead end-to-end design and engineering of steerable catheter products, from concept through commercialization.
- Author and own design specifications, design history files (DHFs), risk analyses (FMEA/FTA), and verification & validation protocols.
- Define and document design inputs and outputs in alignment with FDA 21 CFR Part 820 and ISO 13485 quality systems.
- Select materials, manufacturing processes, and design architectures appropriate for catheter performance, biocompatibility, and manufacturability - with a strong eye toward DFM/DFA.
- Own BOM structure and routing management; maintain accurate manufacturing records in compliance with ISO 13485.
Design Transfer & Manufacturing Ramp- Lead structured design transfer to contract manufacturing partners, ensuring manufacturing requirements are clearly defined, documented, and controlled.
- Drive process validation programs (IQ/OQ/PQ) from protocol authorship through execution and report approval.
- Conduct DFM/DFA reviews throughout development to ensure designs are manufacturable at target cost and quality levels.
- Build and qualify the supplier base for steerable catheter components; manage ongoing supplier quality including incoming inspection criteria and corrective actions.
Regulatory & Quality- Coordinate V&V testing programs - write protocols, oversee execution, and author test reports that meet FDA submission standards.
- Maintain and update technical files and DHFs to support audits, NCRs, and post-market surveillance.
- Proactively identify and mitigate regulatory risks throughout the product development lifecycle.
Contract Manufacturing & Supply Chain- Serve as the primary technical interface with contract manufacturing partners.
- Drive component sourcing, vendor qualification, and supply risk management for catheter subassemblies and raw materials.
- Manage supplier quality requirements including incoming inspection and corrective action processes.
Project Management- Own project plans, milestones, and resource coordination across design, regulatory, manufacturing, and quality workstreams.
- Manage budgets and timelines for development programs from prototype builds through first commercial shipment.
- Coordinate product launch logistics including labeling, packaging validation, sterility testing, and distribution readiness.
- Provide regular project status updates to leadership; escalate risks and drive decisions proactively.
Minimum Qualifications
- 5+ years of medical device engineering experience with a strong focus on catheter or flexible tubular device development.
- Demonstrated track record of taking a steerable catheter through FDA regulatory clearance or approval (510(k) or equivalent) as the lead engineer - not a supporting contributor.
- Hands-on experience authoring DHFs, V&V protocols, IQ/OQ/PQ documentation, and regulatory submission technical sections.
- Proven experience managing contract manufacturers for catheter assembly.
- Deep familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Nice to Have
- Experience with balloon catheter design or multi-lumen extrusion
- Hydrophilic and lubricious coating specification and qualification
- Laser cutting processes for catheter components
- Biocompatibility testing (ISO 10993)
- CAD proficiency (SolidWorks or equivalent)
