Sr. Process Development Engineer

Shifamed; Los Gatos (CA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Akura Medical, a Shifamed portfolio company, seeks a Senior Process Development Engineer to advance manufacturing processes for vascular devices. You will work across functions to develop, verify, and validate new methods, and document progress through MPIs, qualifications, and validation reports.

The role requires 5–8 years in the medical device field, expertise in DFMEA, process validation, and SolidWorks CAD for fixture design. A cleanroom environment experience is preferred.

Qualifications

• Cross-functional collaboration to develop, verify and validate processes.
• Ability to design and fabricate assembly fixtures and manufacturing equipment.
• Experience with design for manufacturing and process development for stent manufacturing (laser cutting, shape setting, microblasting, electropolishing).
• Experience with quality systems and FDA/ISO regulations.

Responsibilities

• Provide creative solutions to satisfy unmet clinical needs through innovative manufacturing processes.
• Work with cross-functional teams to validate processes through bench, in-vitro, and in-vivo testing.
• Document work in lab notebooks, MPIs, equipment qualifications, and process validation.
• Research, develop, modify and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
• Support regulatory/clinical, marketing, and sales efforts with technical input.
• Lead risk management activities including FMEAs and CAPAs.
• Develop test protocols and write test reports for product verification and validation.
• Manage supplier selection and vendor relations.

Skills

Cross-functional teamwork

Statistical analysis

Problem solving

Regulatory awareness

Education

Bachelor's or Master's in Engineering

Tools

SolidWorks

Job 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.

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.

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

• 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 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 $130,000 to $160,000 + 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 [e-mail].