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Senior Test Method Validation Engineer

Lancesoft

Santa Clara, CA

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JOB DETAILS
SALARY
$50
LOCATION
Santa Clara, CA
POSTED
20 days ago
Title: Senior Test Method Validation Engineer
Location:Santa Clara, CA 95054
Duration: 06 Months

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.

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 client, 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

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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