Senior Reliability Engineer

California, USA
July 13, 2021

Company Description

Elevate is a next generation medical device company. We believe that by putting patients and design first, we can disrupt an industry that has remained stagnant for decades. Our team of passionate engineers, designers and doers are analyzing, designing, prototyping, and manufacturing the next new product category in healthcare.

Our team combines expertise from decades in orthopedic bracing with the rapid product design process born in the tech industry. We blend this with a rich focus on product-market fit and deep ethnographic research. With our unique approach, we not only create better products and experiences, but also develop them in a fraction of the time compared to traditional medical device companies.

As a Senior Reliability Engineer, you will be directly responsible for designing, building, and maintaining Elevate’s product testing capabilities. Testing is a critical piece of product development and sustaining quality and the Elevate Reliability Engineer plays a pivotal role in ensuring our testing is best in class. The Reliability Engineer role requires creativity, collaboration, and an attention to details. This individual has a robust knowledge of testing standards and methods from various industries and takes a hands-on approach to designing, building, and maintaining various testing equipment. The Reliability Engineer collaborates with the design team during the development process and identifies opportunities to verify and/or validate design inputs using various testing methods such as static, cyclical, environmental, accelerated aging, usability, etc. In addition to the development of testing capabilities, the Reliability Engineer also develops test protocols, executes testing, and documents test results utilizing statistical analysis to provide maximum confidence in the design of the product. In addition to the testing developed and performed to support product development, the Elevate Reliability Engineer also performs product evaluations as part of returns and plays a crucial role in leading the investigation of root cause and testing to evaluate product malfunctions.

Your responsibilities

  • Develop testing requirements driven by human factors considerations and failure mode analysis in partnership with the Design team
  • Document product performance specifications and acceptance criteria utilizing appropriate statistical methodologies
  • Design, build, and/or acquire testing equipment
  • Benchmark competitor products
  • Develop and document test protocols
  • Execute testing both domestically and with international manufacturing partners
  • Document test results
  • Lead root cause analysis and product malfunction investigations
  • Reference and utilize established testing standards (ISO, ASTM, AATCC, etc.) as applicable to inform testing methods for product reliability and compliance
  • Create reliability standards for suppliers and monitor compliance
  • Conduct on-site audits of supplier’s processes and compliance
  • Execute an industry-leading approach to product feedback and user testing with clinicians and patients
  • This position will report to the VP, Operations and Quality
  • This position may require travel within California (~10%) and to Asia (~10%), global health situation permitting

Key qualifications

  • 3+ years of combined experience in test engineering and/or mechanical engineering, developing robust testing capabilities
  • 2+ years of experience with medical device verification and validation process and FDA Class I / II QMS requirements
  • Working knowledge of standardized testing methods
  • Ability to develop a test from initial concept through test execution and reporting
  • Proficient in utilizing CAD to design and document testing fixtures, tools, and equipment
  • Experience designing complex testing equipment for manufacture by various methods
  • Collaboration with the Design team during product development
  • Understanding of best practices in medical device testing and documentation
  • Understanding of manufacturing processes and mass production environments
  • Extremely self-motivated and proactive with demonstrated critical thinking abilities
  • Proven demonstration of statistical methods and analyses with capability to interpret and report out results
  • Proficient in JMP, Minitab, or other similar statistical analysis software
  • Excellent written communication skills
  • Highly curious with a passion for breaking stuff and documenting findings
  • Currently resident in either San Diego, CA or the San Francisco Bay Area

Awesome additions

  • Willing to take risks and drive change within the company (even as a new employee!)
  • Insatiable desire to learn new things (technologies, testing techniques, clinical information)
  • You are an executor. You simply get things done on time and above expectations.

Education

  • Bachelors in Mechanical Engineering or similar

Company perks

  • Unlimited vacation
  • Teams based in San Diego and San Francisco
  • Healthcare and Dental benefits
  • Remote working encouraged

Elevate Dynamics is an equal opportunity employer; applicants are considered for all roles without regard to race, color, religious creed, sex, national origin, citizen ship status, age, physical or mental disability, sexual orientation, marital, parental, veteran or military status, unfavorable military discharge, or any other status protected by federal, state or local law.

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