Sr. QA Engineer

Description

The Sr. Product Quality Assurance Engineer works as part of the cross-functional product development team and focuses on planning and execution of product quality assurance tasks and testing.

Responsibilities

1. Planning and execution of Product Quality Assurance tasks and testing with hands-on test development and qualification.
2. Material selection and qualification.
3. Collaboration with Product Development on POC and design assessments including biocompatibility assessment and testing as applicable.
4. Product specification validation; overseeing and conducting process validation.
5. Participation in Design Verification & Validation testing.
6. Review and editing of Engineering protocols and reports.
7. Performance of risk assessments, FMEA, and management activities.
8. Data collection and statistical analysis.
9. Writing protocols and reports.
10. Other duties as assigned by manager.

Requirements

1. Medical Device Design and Development Processes.
2. 3 to 5 years’ experience working as a Product Quality Engineer.
3. Success working as part of a cross-functional team member.
4. Electro-Mechanical Device Development and Testing.
5. BS in Engineering and/or related science.
6. Experience and knowledge of Quality Management Systems (QMS).
7. Knowledge of conducting statistical analysis.
8. Quality Assurance Applications – Design Control Knowledge.
9. Design Assurance Testing and Test Qualification.
10. Familiarity with Firmware and Software Program Validation.
11. Familiarity with Reliability Testing and Analysis.

Preferred

1. Robotic medical device development experience.
2. Quality Engineer Certification.
3. Lean/Six Sigma Training and/or Certification.
4. Robotics and Systems Engineering.
5. Minitab or other statistical program experience.
6. Design Tolerance Analysis and methods.
7. Solid Works / CAD expertise.
8. Calibration training and expertise.
9. Some level of experience with Firmware and Software Program Validation.
10. Some level of experience conducting Reliability Testing and Analysis.

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 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.