Principal Mechanical Design Engineer at Shifamed

Doha, , Qatar -

Full Time

Start Date

Immediate

Expiry Date

15 Sep, 26

Salary

0.0

Posted On

17 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Design, SolidWorks, Injection Molding, DFM/DFS, Medical Device Development, Electromechanical Design, V&V Testing, FEA, Tolerance Analysis, Material Selection, Root-Cause Analysis, ISO 13485, FDA Regulatory Frameworks, RIM Molding, Prototype Development, Supplier Management

Industry

Medical Equipment Manufacturing

Description

Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar. To learn more about Akura Medical, please visit www.akuramed.com. ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. Description: This position represents an exciting opportunity to join the Akura team at an early stage where you will creatively design and develop components, both consumable and capital equipment, of a blood clot removal system. The role focuses on mechanical design of various components and assemblies for catheter systems, a console, and cross-functional leadership from concept through high volume manufacturing. You will be responsible for the design, vendor relationships and testing per applicable standards. This is a full-time, on-site position at our Doha, Qatar office. Responsibilities, Skills & Hands-On Experience: * Lead design and development of plastic/composite and metallic parts from concept to high volume manufacturing; drive DFM/DFS, manufacturing and tooling decisions with suppliers. * Drive the full mechanical lifecycle: requirements, concepts, prototyping, detailed design, V&V, and transition to production. * Integrate mechanical designs with electronics, firmware, fluid, and user-interface elements in collaboration with cross-functional teams. * Guide analysis (tolerance stacks, FEA, material selection, root-cause) on critical subsystems. * Creative solutions and product designs to satisfy unmet clinical needs in thrombectomy. * Be a primary contributor to the intellectual property position of the company via invention disclosures and prototypes to demonstrate reduction to practice. * Interact with physicians to assist with product demonstrations and product testing. * Effectively document work throughout the development process though design reviews, manufacturing instructions, test methods, and test reports. * Expertise in design and development of medical devices. * Expertise in electromechanical and mechanism design of durable medical devices. * Substantial experience in design of higher volume disposable components. * Substantial experience in design for molding and machining. * Substantial experience in design for manufacturing. Pilot production experience. * Expertise in product, tool and fixture design using SolidWorks. * Performance test apparatus and test method development. * Process development on both a prototype and manufacturing level. * Mentoring and assisting team members with less experience. * Participating in lab and cleanroom environment builds. * Process optimization and design of experiment based on statistical methodology. * Selecting and managing suppliers, including understanding of capabilities, materials, and fabrication processes * Working independently and in a project team setting. * Supporting regulatory filings including writing technical sections and providing general technical input. Education & Work Experience: * Bachelor's Degree or higher in Mechanical/Biomedical Engineering. * At least 15 years of experience in complex product development, including regulated products. * Advanced SolidWorks proficiency. * Demonstrated track record as a lead/principal engineer or product design of medical devices from concept through launch. * Strong expertise in injection molding and RIM molding (part design, materials, DFM, cosmetic and structural considerations). * Strong experience with medical devices under FDA/ISO 13485 or equivalent regulatory frameworks. * Previous experience working with clinical testing, trials, data collection, and statistical analysis. Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.

Responsibilities

Lead the mechanical design and development of consumable and capital equipment for a blood clot removal system from concept to high-volume manufacturing. Coordinate cross-functional integration of electronics, firmware, and fluids while managing vendor relationships and regulatory documentation.