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Senior Staff Failure Analysis Engineer (QA)

Eargo

Eargo

Quality Assurance
San Jose, CA, USA
Posted on Wednesday, September 6, 2023
We’re Eargo and we’re on a mission to disrupt, innovate, and reimage the hearing industry. If you believe fun at work is non-negotiable and want to experience the joy of being a part of helping someone hear life to the fullest again— expect tears of joy— then this is the place for you! Our passionate, fast-paced, energetic team is driven by the belief that people shouldn’t feel like they need a hearing aid—they should want one. So, if working with some of the coolest, most talented folks around and making an impact every single day sounds like a dream gig, then we want to hear from you!
Summary
The Senior Staff QA Engineer (Failure Analysis) is responsible for the leadership, strategic direction, and development of Eargo’s failure analysis team and may include the direct supervision of failure analysis engineers and technicians. The Senior Staff QA Engineer (Failure Analysis) is responsible for ensuring the failure analysis team, meets or exceeds its failure analysis goals and schedule deliverables. This includes all technical activities including field device failures, as well as design control activities. The Senior Staff QA Engineer (Failure Analysis) will also support Quality System and Quality Engineering in oversight at contract manufacturers and vendors. This is a high impact role which requires deep experience in being a team lead for a failure analysis team. It involves working cross functionally across the company to drive improving product quality and reliability, by understanding customer issues and feeding that information back into the design process. As a leader, they must have the vision, communication ability, technical knowledge, drive, and team-building skills to build a world-class team and support an agile quality culture across the organization.

Essential Job Duties and Responsibilities

  • Critical Thinking: Skilled at finding logical flaws in arguments and plans; identifies problems and solutions that others might miss; provides detailed insight and constructive criticism into problems and complex situations
  • Working with Ambiguity: Achieves forward progress in the face of poorly defined situations and/or unclear goals; able to work effectively with limited or partial information
  • Making Accurate Judgments and Decisions: Bases decisions on a systematic review of relevant facts and information; avoids making assumptions or rushing to judgment; provides clear rationale for decisions
  • Displaying Technical Expertise: Keeps his/her technical skills current; effectively applies specialized system/product knowledge and skills to perform work tasks; understands and masters the technical skills, knowledge, and tasks associated with his/her job; shares technical expertise with others
  • Solving Complex Problems: Breaks down large problems into smaller, more manageable components; identifies key factors that influence the viability of different solutions; clarifies information needed to solve problems
  • Failure Analysis: Gather and analyze data to identify trends associated with device failures; Report data to cross functional teams and use trends to drive priorities; Design experiments to pinpoint root causes for device failures; Identify actions to address device failures; Provide leadership and training to quality technicians
  • Compliance: Documentation of CAPA activities that may be associated with failure analysis; Verify that corrective and preventive actions are communicated as necessary to contract manufacturers and vendors; Monitor effectiveness of implemented actions
  • Audit: Participate as a member of the internal audit team; Conduct internal audits, assign and drive corrective action tasks to completion, and perform verification and effectiveness reviews as required; Participate as a member of the supplier audit team; Generate, manage and drive to closure SCARs opened for CMs
  • Internal Quality System Management: Complaint management and trending; CAPA management; NCMR & SCAR management; Change management; Internal Audit logistics and execution

Requirements

  • Master’s or equivalent experience preferred
  • Typically requires 8 to 12 years of experience in Product Engineering, Device Engineering, or Design Engineering, depending on level of education and experience
  • Experience in medical quality engineering or equivalent regulated environment a plus
  • Strong understanding of data analysis and data visualization
  • Background working with large datasets and applying statistical methods to draw conclusions
  • Critical thinker with solid analytical, technical writing, and communication skills
  • Preference for working in a collaborative group and cross-functional team environment with a strong sense of initiative to sustain product quality and reliability
  • Self-motivated, data-driven, independent, and can clearly assess and manage risk
  • Self-starter, able to make decisions independently with minimal oversight Sets high expectations with internal teams and suppliers and drives best-in-class performance and continuous improvements Strong interpersonal skills a must with the ability to interact with all levels of the organization
  • Demonstrated experience in technical project/program leadership and process management
  • Lean and/or Six Sigma experience a plus
Not accepting third party agency submission for this role.
Eargo is an equal opportunity employer that is committed to hiring a diverse workforce. We welcome all applicants and employees without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. We value unique contributions and openly welcome individuals of all perspectives, experience and backgrounds to apply!