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 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
• 7+ 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

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(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.