Senior Medical Device Process Engineer – Equity & Benefits

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

Job summary

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

Qualifications

• Bachelor's or Master's degree in an engineering discipline.
• 5–8 years of medical device industry experience.
• Experience with stent manufacturing processes (laser cutting, shape setting, microblasting, electropolishing).
• Design and fabrication of assembly fixtures.
• SolidWorks or CAD proficiency; lab and clean room exposure.
• Experience with Nitinol material properties and catheter manufacturing (braiding, lamination, tip forming).
• Lean manufacturing/Six Sigma; process ownership from concept to commercialization.
• Experience with FDA QSR, ISO 13485 compliance.

Responsibilities

• Develop and optimize manufacturing processes for catheter, nitinol, and console products.
• Document work in lab notebooks, MPIs, validations, and design reviews.
• Research, develop, modify manufacturing methods and perform IQ/OQ/PQ validations and gauge R&R.
• Support quality processes, CAPA, change management, audits, and investigations.
• Design, execute, and analyze experiments using statistical methods.
• Participate in risk management and ownership of process FMEAs.
• Develop test protocols and reports for verification/validation activities.
• Select and manage critical suppliers and vendors; provide regulatory/clinical support.

Skills

Effective communication

Cross-functional teamwork

Problem solving

Statistical analysis

Education

Bachelor's or Master's in Engineering

Tools

SolidWorks

CAD

Lab/clean room equipment

Job 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