Description
The Quality Assurance Engineer (QAE) supports the New Product Development (NPD) team, working cross-functionally to support various Quality activities including design controls, V&V planning, QA test development, and application/execution of the QMS. This role specializes in QA vs. QC, and requires familiarity with the Medical Device Product Development process. (PDP)
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 strong attention to detail as well as the capability to both collaborate effectively and work independently.
Responsibilities
- Hands-on test development and qualification, along with participation in design reviews, design verification, and validation testing.
- Evaluation and processing of design change qualifications, assisting with the development of product specifications.
- Risk evaluation and assessment, including data collection and statistical analysis as well as review of Engineering protocols and reports.
- Composition and submission of protocols and reports if applicable, as well as other QMS or other Quality-related responsibilities as assigned.
- Provision of guidance to more junior Quality team members as appropriate.
Requirements
- 2-4+ years' professional experience in QA or similar with medical device industry experience, ideally in new product development. (NPD)
- Electromechanical device development and testing experience.
- Prior background with and knowledge of Quality Management Systems. (QMS)
- Bachelor's degree in Biomedical Engineering or related field.
- Former experience with and ability to apply statistical analysis tools.
- Familiarity with and ideally some level of experience with firmware and/or software validation.
Preferred:
- Robotics or systems engineering experience within the medical device industry.
- Quality Engineer Certification.
- Lean/Six Sigma Training and/or Certification.
- Minitab or other statistical program experience.
- Design Tolerance Analysis and methods.
- Familiarity with Solid Works / CAD.
About Myomo, Inc
Myomo, Inc. is a medical myoelectric company that offers expanded mobility for those suffering from neurological disorders and upper-limb paralysis. Myomo develops and markets 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 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 MS, BPI, 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.