Senior R&D Process Engineer
Senior R&D Process Engineer
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Job Description
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:
Bachelors 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
$88800 - $142300 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 contractors legal duty to furnish information.Required Experience:
Senior IC
Employment Type
Full-Time
