Senior Medical Device Process Engineer – Nitinol & Catheter

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

Benefits offered by this job

Equity

Competitive salary

Benefits

Job summary

Akura Medical, a Shifamed portfolio company, seeks a Senior Process Development Engineer to design and develop processes for catheter, nitinol and console manufacturing. You will perform bench-to-production development, with IQ/OQ/PQ validations, process optimization, and cross-functional collaboration to enable scalable manufacturing.

Responsibilities include documentation, equipment selection, supplier management, and support for regulatory activities.

Qualifications

• Bachelor's or Master's degree in an Engineering discipline.
• 5-8 years of medical device industry experience with process development.
• Experience with design for manufacturing for catheter/nitinol products.
• Strong knowledge of GMP/quality systems and FDA ISO requirements.

Responsibilities

• Design, develop, and optimize manufacturing processes for catheter, nitinol, and console products.
• Own IQ/OQ/PQ validations and ensure process capability and reliability.
• Document experiments, test protocols, risk analyses, and process validations.
• Collaborate cross-functionally, support supplier qualification, and assist regulatory activities.

Skills

Team collaboration

Communication skills

Lean manufacturing

Quality systems knowledge

Education

Engineering degree (Bachelor's or Master's)

Tools

SolidWorks

Job description

Akura Medical, a Shifamed portfolio company, seeks a Senior Process Development Engineer to design and develop processes for catheter, nitinol and console manufacturing. You will perform bench-to-production development, with IQ/OQ/PQ validations, process optimization, and cross-functional collaboration to enable scalable manufacturing.

Responsibilities include documentation, equipment selection, supplier management, and support for regulatory activities.