Quality Assurance Engineer

Quality Assurance Engineer

Department: Quality

Employment Type: Full Time

Location: Burlington, MA

Compensation: $90,000 - $120,000 / year

Description

Why should you join our success story?

Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord, or nerve injury. (E.g. brachial plexus injury or other neuro-muscular disabilities.) It is the only device that, sensing a patient's own neurological signals through non-invasive wearable sensors, can restore the ability to use their arms and hands so that they can live independently, increase their quality of life, reduce cost of care, and return to work. Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment with the MyoPro. Our technology has been referred by leading-edge rehabilitation facilities including Mayo Clinic, Kennedy Krieger Institute, Cleveland Clinic, Loma Linda Medical Center, Massachusetts General Hospital, numerous VA Hospitals, and more. Myomo is headquartered in Burlington, Massachusetts, with sales and clinical professionals across the U.S.

What we're looking for:

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, requiring familiarity with the Medical Device Product Development process. (PDP)

Our 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.

How You'll Drive Impact:

• Hands-on test development and qualification, along with participation in design reviews, design verification, and validation testing.
• Participate in the development, review, and approval of quality documentation including SOPs, work instructions, specifications, and protocols.
• 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.
• Support Product Development Life Cycle from concept through production.
• Participate in risk management activities including review failure mode effects analysis (FMEA).
• Collaborate with the team to drive Quality improvement projects and corrective and preventative actions (CAPA).

What You'll Bring:

• 2-3+ 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.
• Knowledge of ISO 14971 and ISO 13485 regulatory requirements.
• Minitab or other statistical program experience.
• Problem-solving techniques and root cause analysis, 5 Why, etc.
• Design Tolerance Analysis and methods.
• Familiarity with Solid Works / CAD.