Catheter Engineer - Medical Device Design and Manufacturing

VerAvanti • Bothell, WA

83d

About The Position

We are seeking a Catheter Engineer to join our R&D and manufacturing team. In this role, you are responsible for developing, optimizing and maintaining small-scale assembly processes and equipment to support the production of precision sub millimeter dimension imaging catheters. There is opportunity to contribute to the development of new products, and an expectation to lead design changes for improved manufacturability, quality and cost of existing products. Key skills include using precision tools and microscopes, SolidWorks part and drawing changes, and adjusting processes for improved yields, quality and tact time. The engineer supports fixture maintenance to ensure minimal downtime and optimal performance. The ideal candidate is a hands-on creative problem-solver with strong root cause analysis skills from knowing the assembly first hand. This position is team-oriented and collaborative. This position offers opportunities for equity participation, competitive benefits, and professional growth in a dynamic healthcare-focused environment.

Requirements

• Bachelor's or Master's degree in Mechanical or Manufacturing Engineering or a related field.
• 3+ years of experience in micro assembly design and manufacturing engineering; preferably in the medical device industry, or industry with precision instruments (Oculus, Spiration, Olympus, Phillips, Stryker, Sonosite, etc).
• Proficiency with microscopes, precision measuring instruments and tweezers.
• Familiarity with regulatory standards, including ISO 13485 and EN 13485 for quality management in medical devices.
• An experienced technical writer comfortable with internal peer or FDA review of ones work.
• Hands-On small part assembly experience under a micro-scope or vision system is a must.
• Fluency in SolidWorks for 3D modeling, assembly design, and simulation; experience with other low cost CAD tools (e.g., FreeCAD) is a plus.
• Strong understanding of precision engineering principles, including GD&T tolerances, materials selection (e.g., polymers, metals), and manufacturing methods (e.g., injection molding, extrusion, CNC machining), Gauge R&R, Root Cause Analysis Methods.
• Crisp communication skills, with the ability to present ideas clearly to technical and non-technical stakeholders.
• Proven team player who thrives in collaborative settings and contributes to group problem-solving.
• Creative vision with a passion for innovation, demonstrated through conceptual design and out-of-the-box thinking.
• Proficiency in Microsoft Office Suite and engineering analysis tools (e.g., FEA software).

Nice To Haves

• Knowledgeable in automated assembly equipment and robotics is a plus.
• Experience in product design for medical devices, such as catheters or biopsy tools, is highly desirable.

Responsibilities

• Design and develop manufacturing fixtures, jigs, and tooling to ensure efficient, repeatable production of micro-scale components and subassemblies using precision tools, microscopic video displays, and microscopes.
• Create and optimize manufacturing processes that support the use of the above custom tooling as well as the use of micro laser welding, fiber splicing and UV gluing manufacturing.
• Collaborate with cross-functional teams (e.g., R&D, quality assurance, and production) to iterate designs, troubleshoot issues, and implement improvements.
• Provide peer review of new medical device designs, including biopsy tools, from concept through prototyping, reviewing compliance with regulatory standards and user needs.
• May perform mechanical analysis, simulations, and testing to validate designs for functionality, durability, and safety.
• Author or conduct verification efforts for manufacturing process changes.
• Generate technical documentation, including drawings, specifications, and reports, to support product development and manufacturing transitions to design freeze and scale up.
• Stay abreast of industry trends and incorporate innovative solutions to enhance product performance, lower costs and improve manufacturability.

Benefits

• Competitive market salary commensurate with experience.
• Comprehensive healthcare benefits, including medical, and vision coverage.
• Generous Paid Time Off (PTO) policy to support work-life balance.
• Equity participation opportunities allowing you to share in the company's success.
• Professional development resources, including training and conference attendance.
• A supportive, inclusive workplace with flexible hours and opportunities for advancement.
• Available Relocation Package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level