Quality Engineer

3 days ago

Burlington, United States Myomo, Inc. Full time

Have you ever felt that healthcare as an industry represents opportunities for growth? That - while treatments and outcomes are more impressive than ever due to many advancements of modern medicine - the patient experience still leaves much to be desired?


Would you like to be part of not only a cutting-edge drive to not only improve clinical outcomes through technology, along with a commitment to prioritize and serve the patient?


Myomo, Inc. is a medical myoelectric company offering expanded mobility for those suffering from neurological disorders and upper-limb paralysis.


We are 1st in the U.S. to develop and market the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in the paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord or nerve injury such as brachial plexus injury, or other neuro-muscular disability such as amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). It is the only device that, sensing a patient’s own neurological signals through non-invasive sensors on the arm, can restore their ability to use their arms and hands so that they can return to work, live independently and reduce their cost of care.


At Myomo, we are driven by a mission to enable independence and confidence for stroke survivors as well as those living with ALS, MS, and other neurological disorders. Our teams continue to break through barriers, defining the limits of what is possible in both medical device robotics and our global system of care.


We are currently seeking a Quality Engineer to provide support to our QC Engineering Manager and team. The core aspects of this role are to focus on non-conforming materials, establish effective inspection methods, resolve supplier quality issues, and collaborate with Product Development to deliver effective product testing, validation, and inspection.


He/she will also assist in the implementation of appropriate systems, policies, and procedures to ensure quality and compliance and proactively develop improved processes.


The ideal candidate is a well-organized, process-oriented, and systematic-minded professional who is able to keep an eye toward process improvements and innovation. Keys to success in this role include the ability to demonstrate attention to detail as well as the capability to both collaborate effectively and work independently. He/she will be able to understand and incorporate the viewpoints of cross-functional stakeholders.


Responsibilities

  • Develop, document, and maintain test systems for Myomo’s core products.
  • Conduct Product Testing as required.
  • Conduct RMA investigations and root cause analysis.
  • Perform Qualification of product component replacements and substitutes.
  • Facilitate Supplier qualifications.
  • Help execute Mfg. process validations and testing.
  • Documentation of test procedures.
  • Write ISPEC’s for components for various product lines.
  • Conduct and support investigation of NCMR’s, CAPA’s, SCAR’s.
  • Develop and implement effective corrective actions.
  • Execution of software validation/ fixture qualifications.
  • Assist QC Engineering Manager with various quality tasks.


Requirements

  • Bachelor's degree in a related Engineering discipline with 1+ year of experience. (2+ years' professional experience preferred)
  • Experience with test development and documentation.
  • Basic mechanical assembly including being able to work from a drawing.
  • Experience with basic circuit analysis.
  • Fundamental electronic assembly skill level including soldering, and components identification.
  • Software QA testing or fixture testing.
  • Attention to detail and ability to follow written instructions.
  • Ability to learn new skills and adapt to a small rapidly changing team.


Preferred:

  • Computer Science or Electrical Engineering Coursework.
  • Medical Device GMPs and working in a regulated environment.
  • Knowledge and use of basic statistics.
  • CAD/Solidworks.
  • Quality Engineer certification.

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