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Sr. Process Development Engineer
Job Location:
Job Location:
Los Gatos, CA - USA
Yearly Salary:
USD 130000 - 160000
Yearly Salary:
Posted:
29 September 2026 (22 hours ago)
Posted:
Application Deadline:
27 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Akura Medical a Shifamed portfolio company is advancing a differentiated platform for the treatment of venous thromboembolism (VTE) which affects up to 900000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana Thrombectomy System in acute pulmonary embolism 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:
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 companys 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 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 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
Education & Work Experience:
- Bachelors or Masters 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 Lab and clean room environment exposure.
- Excellent communication skills ability to work independently or in project team setting.
- Experience with Nitinol material properties and processing Catheter manufacturing (braiding lamination tip forming thermal bonds)
- Process ownership from concept to commercialization Lean manufacturing/Six Sigma
- Experience working under quality systems designed to meet governmental regulations.
- Familiarity with FDA QSR ISO 13485.
- Must be proficient in Solidworks/CAD Comfortable working in a clean room environment.
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. The base salary range for this full-time position is between $130000 to $160000 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
Required Experience:
Senior IC
