Position Summary:
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.
Pay - $50/hr to $55/hr
Primary Responsibilities:
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 Abbott, 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
Required Qualifications:
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
Preferred Qualifications:
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
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually as applicable.
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