Sr. Process Development Engineer, Akura Medical

Akura Medical, a Shifamed Portfolio Company, is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths. 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 will help design and develop processes for catheter manufacturing, focusing specifically on Nitinol based components. The process development engineer 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, Nitinol component manufacturing, process optimization, equipment selection and operation and verification & validation activities. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience

• 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 analyze 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.

• Design for manufacturing.

• Previous experience in process development for Nitinol manufacturing is required.

• Experience with Femto/Fiber laser cutting and CAM programming.

• Shape setting of Nitinol frames. Design and fabrication of shape setting tooling and assembly fixtures.

• Salt pot operation and automation.

• Grit blasting and Electropolishing.

• Catheter shaft braiding, laminating, and adhesive bonding expertise required.

• Experience with processing methods (dipcoating, spraying and injection molding) of polymeric urethane films/coating. Experience with radiopaque doping of polymeric coatings a plus.

• Experience with Lab and clean room environment.

• Excellent communication skills, ability to work independently or creatively with the R&D team.

Preferred Skills & Hands-On Experience

• Nitinol component processing and manufacturing.

• Electromechanical box build and soldering experience preferred.

• Process ownership from concept to commercialization.

• Lean manufacturing/Six Sigma.

Education & Work Experience

• Bachelor's or master's degree in Engineering.

• 7+ years of medical device industry experience.

• Previous experience working with medical device development.

• Experience working under quality systems designed to meet governmental regulations. Familiarity with FDA QSR, ISO 13485.

• Effective verbal and written communication skills.

• Excellent attention to detail, flexible, and adaptable to change.

• Must have excellent problem-solving skills, ability to diagnose issues, find and test solutions.

• Must be proficient in Solidworks/CAD.

• Comfortable working in a clean room environment.

• Previous experience working in a startup environment.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits.

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.