Senior Test Method Validation Engineer

We are recruiting for our next Senior Test Method Validation Engineer to join our team in our Santa Clara, CA location.

In this role, you will be part of a product development team focused on delivering future transcatheter valve technologies to the global healthcare market. This role will potentially involve a range of responsibilities including but not limited to testing and data analysis, design concept generation, and test method development and validation.

* Lead test method validation protocol development, execution, statistical analysis, and reports

* Involved in requirement development to influence design goals

* Involved in test method and model development

* Complete testing and data analysis to achieve design and process development goals

* Under guidance, generating design concepts to meet specific design goals

* Identify potential issues with designs and test methods, perform root cause analysis

* Work with internal departments and outside vendors to obtain prototype parts and fixtures

* Understanding of measurement system analysis, metrology, gage R&R

* Support development of risk management documentation (DFMEA, UFMEA, PFMEA) -Optional

* Execute activity in support of project goals

* Gain an understanding of the quality and regulatory requirements of our organization, FDA and ISO regulations

* completion of assigned tasks

* Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

* Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

* Performs other related duties and responsibilities, on occasion, as assigned

Candidates must posses 7 or more years experience supporting validation programs and possess a BS degree, preferable in the Science or Engineering fields (or equivalent experience). Give attention to detail, perform critical analysis of situations and provide recommendations, work independently with structured guidance, good follow up skills, clearly define and communicate issues both verbally and in writing.

* Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field

* 5 years' minimum experience designing, testing, manufacturing or other engineering support

* Experience working within a team and as an individual contributor in a fast-paced, changing environment

* Strong verbal and written communications with ability to effectively communicate to all levels of the organization

* Proficient in collaborating with project stakeholders (client and internal) and technical team members

* Multitasks, prioritizes and meets deadlines in timely manner

* Strong organizational and follow-up skills, as well as attention to detail

* Medical device or regulated industry experience

* Solidworks or other CAD experience

* Worked with an electronic document control system (Windchill, etc.)

* Experience working with cross-functional teams in a geographically diverse, matrixed organization