Sr. Process Development Engineer

About the role

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. 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: Akura Medical, a Shifamed portfolio company, is seeking a highly skilled and motivated Senior Process Development Engineer. This position will help design and develop processes for catheter, nitinol and console manufacturing. You will be responsible for hands-on design, development, and manufacturability of the company’s products including specific products, subassemblies, and components. You will be directly involved in development and problem-solving in a wide range of areas including assembling handling methods, component manufacturing, process optimization, equipment selection and operation and verification & validation activities.

Responsibilities

• Provide creative solutions to satisfy unmet clinical needs through creation of innovative processes and methods of manufacture.
• Work as part of a cross-functional team to develop, optimize, verify, and validate processes through bench, in-vitro, and in-vivo testing.
• Effectively document work throughout the development process inclusive of lab notebooks, design reviews, manufacturing process instructions (MPIs), equipment qualifications, and process validation.
• Research, develop, modify and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
• Drive and provide support to quality processes and applying formal problem-solving techniques to determine root cause, and implementing solutions (non-conformance, CAPA, change management, audits, product complaint investigations, etc.).
• Design, execute, and analyse experiments using sound statistical methodology.
• Participate in risk management activities, including development and ownership of process FMEAs.
• Support product verification and validation activities by developing test protocols and writing test reports.
• Select and manage critical suppliers and vendors.
• Provide technical support for regulatory/clinical, marketing, and/or sales efforts.

Qualifications

• Bachelor's, or Master's, degree in an Engineering discipline.
• 5-8 years of medical device industry experience.
• Experience with design for manufacturing and process development for stent manufacturing (laser cutting, shape setting, microblasting, electropolishing).
• Experience with design and fabrication of assembly fixtures.
• Tool and fixture design on Solidworks or equivalent.