Boston Scientific
Senior Design Quality Engineer
Boston Scientific Interventional Oncology & Embolization (IO&E) is the market leader in therapeutics and tools for interventional radiologists, featuring Y90 microspheres, ablation devices, embolic devices and a selection of ancillary products. We are looking for a dynamic Senior Design Quality Engineer to support the growing TheraSphere Y90 franchise. In this role you will work with high-performing cross-functional development teams to maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week. Relocation assistance may be available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position. Your responsibilities will include: Partners with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing Input from concept through commercialization. Uses clinical knowledge to influence how devices are tested and designed Actively drives the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed Updates and maintains product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) to state of the art Leads the development of and coordinates the execution and documentation of Design Verification and Validation activities. Drives Post Market activities such as assessment of risk based on post market signals, field assessments Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Provides project direction, coaching, and mentoring for engineering and technical team personnel to ensure best-in-class Design Quality Engineering practices. What we're looking for in you: Required requirements: Bachelor's degree in an Engineering discipline or related field of study 5+ years of experience in design assurance, quality, or related medical device experience Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards Demonstrated problem-solving, critical thinking, and data analysis capabilities Demonstrated use of Quality tools/methodologies Ability to collaborate and influence across multiple, cross-functional teams Ability to effectively work and collaborate in a remote environment Hands-on approach Preferred qualifications: Comfort with self-directed work in addition to collaboration in a team environment Experience with design changes, complaint reduction, and corrective action Self-starter with the ability to identify improvement opportunities Strong ability to successfully multi-task and adapt Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.
Boston Scientific Interventional Oncology & Embolization (IO&E) is the market leader in therapeutics and tools for interventional radiologists, featuring Y90 microspheres, ablation devices, embolic devices and a selection of ancillary products. We are looking for a dynamic Senior Design Quality Engineer to support the growing TheraSphere Y90 franchise. In this role you will work with high-performing cross-functional development teams to maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week. Relocation assistance may be available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position. Your responsibilities will include: Partners with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing Input from concept through commercialization. Uses clinical knowledge to influence how devices are tested and designed Actively drives the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed Updates and maintains product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) to state of the art Leads the development of and coordinates the execution and documentation of Design Verification and Validation activities. Drives Post Market activities such as assessment of risk based on post market signals, field assessments Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Provides project direction, coaching, and mentoring for engineering and technical team personnel to ensure best-in-class Design Quality Engineering practices. What we're looking for in you: Required requirements: Bachelor's degree in an Engineering discipline or related field of study 5+ years of experience in design assurance, quality, or related medical device experience Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards Demonstrated problem-solving, critical thinking, and data analysis capabilities Demonstrated use of Quality tools/methodologies Ability to collaborate and influence across multiple, cross-functional teams Ability to effectively work and collaborate in a remote environment Hands-on approach Preferred qualifications: Comfort with self-directed work in addition to collaboration in a team environment Experience with design changes, complaint reduction, and corrective action Self-starter with the ability to identify improvement opportunities Strong ability to successfully multi-task and adapt Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.