Test Method Validation Engineer IV

Title: Test Method Validation Engineer IV Location: Santa Clara, California Duration: 7 Months + Extension 100% Onsite 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. Primary Responsibilities Lead test method validation protocol development, execution, statistical analysis, and reportsInvolved in requirement development to influence design goalsInvolved in test method and model developmentComplete testing and data analysis to achieve design and process development goalsUnder guidance, generating design concepts to meet specific design goalsIdentify potential issues with designs and test methods, perform root cause analysisWork with internal departments and outside vendors to obtain prototype parts and fixturesUnderstanding of measurement system analysis, metrology, gage R&RSupport development of risk management documentation (DFMEA, UFMEA, PFMEA) -OptionalExecute activity in support of project goalsGain an understanding of the quality and regulatory requirements of Abbott, FDA and ISO regulationscompletion of assigned tasksComplies 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 vendorsPerforms other related duties and responsibilities, on occasion, as assigned Required Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related field7+ years’ minimum experience designing, testing, manufacturing or other engineering supportExperience working within a team and as an individual contributor in a fast-paced, changing environmentStrong verbal and written communications with ability to effectively communicate to all levels of the organizationProficient in collaborating with project stakeholders (client and internal) and technical team membersMultitasks, prioritizes and meets deadlines in timely mannerStrong organizational and follow-up skills, as well as attention to detail Preferred Qualifications Medical device or regulated industry experienceSolidworks or other CAD experienceWorked with an electronic document control system (Windchill, etc.)Experience working with cross-functional teams in a geographically diverse, matrixed organization Consultants Eligible Benefits Upon Waiting Period Medical and Prescription Drug PlansDental PlanVision PlanHealth Savings Account (for High-Deductible Health Plans)Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)Supplemental Life InsuranceShort Term Disability (coverage varies by state)Long Term DisabilityCritical Illness, Hospital coverage, Accident InsuranceMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance401(k) Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.