Senior R&D Process Engineer

Work Flexibility: Onsite

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 hybrid 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.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.