Test Engineer- II

$80,800 - $121,200/Yr

Medtronic - Los Angeles, CA

Full-time - Entry Level

Los Angeles, CA

10,001+ employees

Miscellaneous Manufacturing

About the position

The Test Engineer II role at Medtronic involves leading product verification and reliability testing within the Mechanical Engineering department. The position focuses on designing, developing, and implementing testing methods for new product development and sustaining projects, ensuring compliance with Medtronic's quality system. The engineer will act as a subject matter expert, guiding the business in executing quality standards and ensuring that all program work products meet reliability and compliance requirements.

Responsibilities

• Plan and execute large and complex medical device product development programs design verification and reliability test strategy.
• Collaborate with systems engineering and product development teams to evaluate designs from a design input requirements/design outputs perspective.
• Plan and execute product design verification and reliability demonstration, applying basic product design verification methods and principles.
• Lead the development, modification, and design review of plans, reports, protocols, and data summaries.
• Use statistical techniques or data analysis to inform design decision making and conclusions for deliverables.
• Partner and review risk management deliverables like DFMEA/PFMEA and Hazard Analysis.
• Utilize risk management and robust design principles to develop test methodologies.
• Assist Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities.
• Participate on project teams and technical review boards, leading change control evaluations.
• Drive clarity and consistency in documentation and lead CAPA projects.
• Participate in support of external and internal regulatory audits and inspections.
• Drive process improvement activities.

Requirements

• Bachelor's degree in engineering or science with 2+ years of work experience in medical device development and/or development quality OR a Master's Degree in Engineering or Science with 0+ years of work experience in medical device development and/or development quality.
• Experience working in a regulated industry (e.g., FDA-regulated) is preferred.
• Bachelor's Degree in Biomedical, Mechanical, Chemical or Electrical preferred.
• Master's Degree in Engineering, Quality, Regulatory, or related is preferred.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
• Understanding of the interdependencies of program work products and guiding teams in execution strategy.
• Experience with planning and executing design verification testing, test method development and validation.
• Experienced with statistical analysis of data (e.g., MiniTab, Weibull ++, etc.).
• Experience with DFMEA, Accelerated Life Testing, Risk Analysis, Reliability Growth, and/or Demonstration Testing.
• Working knowledge of electromechanical devices, battery-powered devices, and/or electrochemical reactions.

Nice-to-haves

• Ability to author technical reports, business correspondence, and standard operating procedures.
• Strong verbal and written English communication skills with the ability to communicate at multiple hierarchical levels in the organization.
• Ability to multi-task, prioritize, meet/exceed deadlines, and hold themselves and others accountable.
• Self-starter with a sharp focus on quality and customer experience.

Benefits

• Competitive Salary
• Flexible Benefits Package
• Short-term incentive called the Medtronic Incentive Plan (MIP)