Quality-Sr Quality Engineer- Medical Device- Boston
3 days ago
About Our Client
This client develops and markets lightweight, powered arm braces to aid individuals with neurological disorders in regaining arm and hand functionality. Their technology, which senses neurological signals through non-invasive sensors, aims to promote independence and reduce healthcare costs for patients.
Job Description
Hands-on test development and qualificationDesign review participation and testing verificationProcessing design change qualificationsAssisting with product specification developmentRisk evaluation, data analysis, and protocol/reports reviewProviding guidance to junior Quality team membersMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
2-4+ years' QA experience in the medical device industry, ideally in new product development (NPD)Electromechanical device development and testing experienceKnowledge and background in Quality Management Systems (QMS)Bachelor's degree in Biomedical Engineering or related fieldProficiency in statistical analysis toolsFamiliarity with firmware and/or software validationPreferred:Robotics or systems engineering experience in the medical device industryQuality Engineer CertificationLean/Six Sigma Training or CertificationProficiency in Minitab or similar statistical programsDesign Tolerance Analysis skillsFamiliarity with SolidWorks/CAD
What's on OfferEngaging in cutting-edge medical device development projects, particularly focusing on new product development (NPD).Contributing to the advancement of electromechanical device technology for improving mobility in individuals with neurological disorders.Involvement in Quality Management System (QMS) activities to ensure regulatory compliance and adherence to industry standards.Collaborating with a multidisciplinary team on design reviews, testing, and validation processes.Access to training and resources for continuous professional development, including potential certifications such as Quality Engineer Certification or Lean/Six Sigma Training.Exposure to innovative tools and software for statistical analysis, firmware, and software validation, enhancing technical skills.Participation in robotics and systems engineering initiatives within the medical device industry, driving innovation and improving patient outcomes.Utilization of design tolerance analysis methods and SolidWorks/CAD software for product development and improvement projects.
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