About the role:The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. You will support product sustainment activities assessing product performance for trends including signal escalation. This position will help lead, communicate, and coordinate complaint reduction and post marketing projects and initiatives. Guarantee compliance with Quality System Regulations, Corporate Quality Manual and corporate and local standard operating procedures. Your Responsibilities Include: Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies). Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling). Owns, creates, maintains and/or supports safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA Perform quality trending using the complaint and NCEP/CAPA systems. Perform and/or lead risk analyses for CAPA and/or audit findings investigations. Assess changes to protect the design intent of a product to meet safety, efficacy, regulatory, and business requirements. Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, ISO, etc.). Lead, communicate, and coordinate complaint reduction and post marketing projects and initiatives and roll-out with cross-functional teams. Communicating product performance by formal presentations to management, cross-functional team members, committees and/or design teams, supporting published product performance reports. Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Understand and support linkage of field data and Risk Management. Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP's, CAPA's PIRs, Field Signals Evaluations and Field Actions. Support internal and external regulatory audits, as required. Responsible for reviewing and developing test method validation protocols and reports. Work with cross functional teams to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components. Design and develop in-process and receiving quality systems for new processes and components Work cross-functionally with other departments to accomplish DA tasks. What we're looking for: Bachelor or Licenciature degree in Chemical, Mechanical, Materials, Biomedical or related. English Level desired: 85-95%. Experience: At least 2 years Desired knowledge: ASQ Certification (CQE, SSGB), Problem Solving, critical thinking. Ability to collaborate and influence across multiple, cross-functional teams. Adept at working in a regulated environment with clinical teams including review of clinical data and analysis of clinical terminology. Strong ability to multi-task and be adaptable. Requisition ID: 581374 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! Benefits • Life-Work Integration • Community • Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.
