We are seeking a talented Process Development Engineer to support the development and commercialization of our next-generation endovascular thrombectomy system, combining a retrievable nitinol stent with a catheter-based delivery and retrieval platform. This engineer will play a critical role in developing and validating manufacturing processes that enable reliable production of highly complex interventional devices.

This role is in Irvine, CA with the expectation to be in office 5 days a week.

Check out our product portfolio: Stryker Inari

Clot Triever portfolio: Clot Triever

What you will do:

• Develop, optimize, and validate processes for nitinol-based implantable components (stent crimping, heat setting, shape recovery, electropolishing).
• Design and qualify custom fixtures and tooling for catheter assembly, nitinol handling, and retrieval system integration.
• Conduct process capability studies (Cp, Cpk, Pp, Ppk) and apply statistical tools (DOE, SPC, ANOVA) to ensure repeatability and scalability.
• Lead IQ/OQ/PQ validations for critical processes such as:
  • Laser welding (catheter to nitinol frame interfaces).
  • Thermal bonding / adhesive bonding of catheter subassemblies.
  • Braiding, coiling, and shaft assembly for deliverability and torque response.
  • Crimping and deployment system verification.
• Collaborate with R&D to translate design intent into robust, commercially scalable processes.
• Support root cause investigations and implement CAPAs for process-related issues.
• Document processes, validations, and risk assessments in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 25539 (vascular implants).

What you need:

Required Qualifications:

• Bachelor's degree in Engineering (Mechanical or Biomedical preferred)
• 2+ years of work experience

Preferred Qualifications:

• Experience in process development/manufacturing engineering within interventional cardiology, peripheral vascular, or neurovascular devices.
• Prior exposure to nitinol stents, catheter delivery systems, or thrombectomy devices is highly preferred.
• Deep understanding of endovascular catheter systems, stents, and retrieval devices.
• Experience with nitinol processing (crimping, heat setting, shape memory characterization).
• Proficiency in fixture/tooling design (SolidWorks, CAD) for catheter & stent integration.
• Skilled in statistical analysis and software (Minitab, JMP).
• Familiarity with risk management (DFMEA, PFMEA) and regulatory expectations for Class II/III interventional devices.
• Hands-on experience with laser welding, thermal bonding, hydrophilic coatings, and catheter extrusion processes.
• Strong communication and documentation skills to interface with R&D, Manufacturing, and Quality teams.
• Six Sigma Green/Black Belt certification

$88,800 - $142,300 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.