Job description

Why work for our company?!

-We’re at the cutting edge of medical device robotics with 0 true 1:1 competitors in the market currently. Our mission is to empower users suffering from partial paralysis to regain function in weak arms and hands impacted by stroke, brachial plexus injury, (BPI) cerebral palsy, and other neuromuscular diseases/impairments.

Through innovative technology developed at MIT with clinical trials conducted at Harvard Medical School and first-of clinical outcomes and patient testimonials, our organization represents what the brightest medical minds can achieve for patients.

-If you take a high level of pride in your work and making a positive impact in patient lives resonates with you, we want to hear from you.

What does our product do?!

Our product is the 1st of its kind to be launched into the commercial market, and it’s being used to support neuro-affected patients (primarily stroke) who have lost function in their arms.

Essentially we’re in a sister space to prosthetics. Our patients have all their limbs and digits but, in our case, they have a “dead” arm - meaning, an arm they are unable to use.

With our product - which is a brace equipped through the latest technologies to tap into our patients’ own brain (EMG) waves and amplify muscle tissue response, our patients are able to restore physical function!!

Since the device “links in” to our patients’ central nervous system, they say when they use our brace, that it feels like moving their own arm themselves. This is where our name is derived! Myomo is short for “My O*wn Mo*tion.”

Find out more about us at: www.myomo.com.

Product Quality Assurance Engineer (QA Engineer)

The Product Quality Assurance Engineer or QA Engineer typically works and is assigned as part of the cross-functional New Product Development team. They specialize in QA vs. Quality Control (QC). They are very familiar with Design Controls, following the QMS, V&V, QA Test Development.

What would you do in this role?!

• Develop, document, and maintain test systems for Myomo’s core products.
• Planning and executing Product Quality Assurance tasks and testing. Hands on Test Development and Qualification.
• Material selection and Qualification. Working with Product Development on POC and Design Assessments.
• Biocompatibility assessment and testing as applicable. Development of Product Specifications.
• Overseeing and conducting Process Validation. Participating in Design Verification & Validation Testing.
• Review and edit of Engineering Protocols and Reports. Performing risk assessments, FMEA, and management activities.
• Data collection and statistical analysis. Writing Protocols and Reports. Other related responsibilities as defined and assigned by Manager.

Requirements/Qualifications

• BS or equivalent in related Engineering discipline and 2+ years of professional experience.
• Medical Device Design and Development Processes. 3 to 5 to years’ experience working as a Product Quality Engineer.
• Success working as part of a cross-functional team member. Electro-Mechanical Device Development and Testing.
• BS in Engineering and/or related science. Experience and knowledge of Quality Management Systems. (QMS)
• Knowledge of conducting statistical analysis including Quality Assurance Applications and Design Control knowledge.
• Design Assurance Testing and Test Qualification. Firmware and Software Program Validation. Reliability testing and analysis.

Preferred Specialized Knowledge:

• Computer Science or Electrical Engineering coursework. Medical Device GMPs and working in a regulated environment.
• Robotic medical device development experience. Quality Engineer Certification.
• Lean/Six Sigma Training and/or Certification. Robotics and Systems Engineering.
• Minitab or other statistical program experience.
• Design Tolerance Analysis and methods.
• SolidWorks / CAD expertise.
• Calibration training and expertise.

Job Type: Full-time

Pay: $105,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Compensation package:

• Bonus pay
• Performance bonus

Experience level:

• 5 years

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Boston, MA 02114: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Medical Device: 2 years (Preferred)
• QA Engineering: 4 years (Preferred)
• Design assurance testing: 1 year (Preferred)
• Software program validation: 1 year (Preferred)

Work Location: Hybrid remote in Boston, MA 02114

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