Principal Mechanical Engineer

About Akura Medical

Akura Medical, part of the Shifamed portfolio, is building a specialized platform for treating venous thromboembolism (VTE), a condition that impacts as many as 900,000 people in the United States each year. The company has secured U.S. IDE approval for its QUADRA-PE study, which is assessing the Katana™ Thrombectomy System in patients with acute pulmonary embolism. Alongside this, Akura Medical is creating NavIQ™, a software platform that converts CT angiograms into detailed 3D pulmonary vascular models to improve visualization, procedural planning, clot assessment, safety, efficacy, and ease of use. The company has also completed a $53 million first close of its Series C round, backed by the Qatar Investment Authority, to support a joint venture and a new R&D and manufacturing facility in Doha, Qatar.

About Shifamed

Shifamed LLC was established in 2009 by entrepreneur Amr Salahieh. It operates as a privately held innovation center focused on developing new medical technologies that address clinical needs in fast-changing areas such as cardiology and ophthalmology.

Role Overview

The Principal Mechanical Engineer will serve as the most senior technical lead responsible for catheter components within the product portfolio.

Key Responsibilities

• Take ownership of the overall mechanical architecture for console and cart systems, covering structural design, enclosures, mechanisms, thermal considerations, serviceability, and manufacturability.
• Direct the development of plastic and composite components, including injection molding and RIM molding, while working with suppliers on design for manufacturing, design for serviceability, and tooling choices.
• Manage the complete mechanical development cycle from defining requirements and exploring concepts through trade studies, prototyping, detailed design, verification and validation, and handoff to production.
• Work closely with cross-functional partners to integrate mechanical solutions with electronics, firmware, fluid systems, and user-interface components.
• Lead technical analysis on key subsystems, including tolerance stack-ups, finite element analysis, material selection, and root-cause investigations.

Requirements

• Bachelor’s or master’s degree in Mechanical Engineering or a closely related discipline.
• At least 15 years of experience in complex capital equipment or electromechanical product development, including work on regulated products.
• Hands-on experience with medical devices developed under FDA, ISO 13485, or comparable regulatory standards.
• Proven success as a lead or principal engineer, or as the product design owner for console- or cart-based systems from concept through launch.
• Deep knowledge of injection molding and RIM molding, including part design, material selection, manufacturability, and cosmetic and structural considerations.
• Advanced proficiency in SolidWorks.
• Experience leading cross-functional product development programs in regulated environments.
• Background working on large console or cart systems that combine fluid handling, power systems, and complex electronics.

Additional Information

Compensation is set using a role, level, and location-based pay structure. Final placement within the range depends on job-related knowledge, work location, skills, experience, relevant education, and any certifications or training.

Candidate Notice

The company and its portfolio businesses do not interview candidates or make offers through mobile web chat applications. Any suspicious activity should be reported to hr@shifamed.com.