Design Assurance Engineer II

Additional Locations:   N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. Title: Design Assurance Engineer 2   About the role:   A Design Assurance Engineer 2 is a quality member that directly supports medical device product development from concept through commercialization. You will support product sustaining activities assessing product performance for trends including signal escalations and design changes. This position will help lead, communicate, and coordinate complaint reduction and post market projects and implementation of design changes. Also, you will guarantee compliance with Quality System Regulations, Corporate Quality Manual and corporate and local standard operating procedures.     Your Responsibilities Include:   · Collaborate and lead to solve complex engineering problems using analysis, experimentation, and statistics. · Apply sound, systematic problem-solving methodologies in prioritizing, communicating, and helping resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies). · Intermediate conceptual knowledge of Design Controls. Assist 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). · Create, maintain and/or support safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report, and DFMEA. · Collaborate with quality trending using the complaint and NCEP/CAPA systems. · Assist, communicate, and coordinate complaint reduction and post market projects and initiatives and roll-out with cross-functional teams. · Communicate 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. · Support and lead project decisions on quality and compliance inputs for post market product sustaining activities, such as design changes, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions. · Contribute with internal and external regulatory audits, as required. · Cooperate and contribute to developing test method validation protocols and reports, and design verification activities. · 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.     What we're looking for:   · Bachelor or Licentiate near-graduates in Chemical, Mechanical, Mechatronics, Materials, Biomedical Engineering or related. · English Level desired: 85-95%. · Experience: 2+ years · Desired knowledge: Problem Solving, critical thinking, statistical tools. · Ability to collaborate across multiple and cross-functional teams. · Strong ability to multi-task and be adaptable.   Preferred Qualifications · Strong presentation and facilitation skills. · Experience with and/or knowledgeable in Quality System Regulations, Medical Device Regulation, and Quality Standards. ·