Staff R&D Test Engineer
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Job Location:
Fremont, CA - USA
Monthly Salary:
$ 116100 - 193400
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Flexibility: Hybrid
What You Will Do:
- Design develop and validate custom benchtop test methods to characterize product performance
- Develop execute and document test protocols and reports to support product development verification validation and regulatory submissions
- Design and validate test methods including Test Method Validation (TMV) and Gage R&R studies
- Analyze test data using statistical tools (e.g. Minitab JMP) and lead structured problem solving for test or product-related issues
- Implement continuous improvement initiatives leveraging lean principles and automation to reduce variability and testing cycle time
- Support root cause investigations CAPAs and change control through structured test analysis
- Maintain and develop custom test fixtures and simulated-use models ensuring physiological relevance for neurovascular applications
- Ensure all test activities are executed in compliance with applicable standards (e.g. ISO 10555 ISO 14971 ISO 13485 FDA 21 CFR Part 820)
What You Will Need:
Required Qualifications:
- Bachelors in Engineering or related discipline
- 4 years of experience in a medical device or other regulated environment
- Proficient in test method development Test method validation Gage R&R and statistical data analysis
- Hands-on knowledge of test equipment such as Instron pressure systems flow loops and tensile/fatigue testers
- Strong documentation practices and understanding of design control risk analysis (ISO 14971) and validation procedures
Preferred Qualifications:
- Experience with liquid embolics catheter stent or guidewire-based devices ideally in neurovascular or cardiovascular domains
- Familiarity with LabVIEW MATLAB or Python for data acquisition and control
- Experience with SolidWorks or similar CAD for fixture development
$116100 - $193400 USD Annual
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
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
