Staff R&D Process Development Engineer
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Job Location:
Irvine, CA - USA
Monthly Salary:
$ 100700 - 165100
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a talented Process Development Engineer to support the development and commercialization of our next generation thrombectomy system. This engineer will play a critical role in developing and validating manufacturing processes that enable reliable production of highly complex interventional devices with strong collaboration with R&D engineering.
This role is fully onsite role in Irvine CA with the expectation to be in office 5 days a week.
Check out our product portfolio: Stryker Inari
What you will do:
Develop optimize and validate manufacturing processes for next generation thrombectomy devices (capital and disposables)
Design and qualify custom fixtures and tooling for catheter assembly nitinol handling and retrieval system integration.
Develop fixtures and equipment for precision assembly and testing of medical devices
Utilize strong understanding ofprocess capability analysis (Cp Cpk Pp Ppk) statistical process control (SPC) and other statistical tools (DOE ANOVA) to ensure process repeatability and scalability
Lead IQ/OQ/PQ validations for critical processes such as:
Injection Molding
Bonding processes (e.g. automated gluing ultrasonic welding etc.)
In-process inspections and testing (e.g. leak testing)
Collaborate with R&D to translate design intent into robust commercially scalable processes including the use of DFM best practices
Support design transfer activities from the R&D environment to a cleanroom environment
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)
4 years of work experience
Preferred Qualifications:
Prior exposure to nitinol stents catheter delivery systems or thrombectomy devices is highly preferred.
Deep understanding of endovascular catheter systems stents and retrieval devices.
Strong level of understanding pertaining to the design for injection molded parts and molding process development
Experience in process development/manufacturing engineering within medical device space specifically for injection molded components
Proficiency in fixture/tooling design using SolidWorks CAD
Skilled in statistical analysis and software (Minitab JMP)
Familiarity with risk management (DFMEA PFMEA) and regulatory expectations for Class II/III interventional devices
Six Sigma Green/Black Belt certification
$100700 - $165100 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:
Staff IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
