Boston Scientific
Design Quality Engineer II
Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): 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. About the Role
We have an exciting opportunity to join the Design Quality team supporting the TheraSphere Y90 device. TheraSphere is a catheter-based, loco-regional radiation therapy. In this role, you will make important contributions to exciting new applications (TDP) and excel in a dynamic, fast-paced environment. This Design Quality Engineer II will work with high-performing cross-functional development teams to develop and maintain the design control deliverables, risk management analysis, and DHF compliance to ensure delivery of the highest quality product to the customer. Boston Scientific values 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:
Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing input. Understand clinical use cases and user interface requirements to drive design decisions and implement through the risk management package. Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) Collaborate with R&D to ensure the design of test assemblies and test method parameters using current analysis techniques and technologies will allow for success in test method validation. Independently drive the test method validation process as well. Monitor field performance against risk assessments. Analyze these data and identify areas of product design to proactively improve field performance. Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed. May include design and execution of structured experimental plans to drive data-based decisions informing the proposed change decision. Support the verification, validation, and usability testing to meet or exceed internal and external requirements. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. What We're Looking For In You:
Required qualifications: Bachelor's degree in an Engineering discipline 2+ 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 use of Quality tools/methodologies Ability to collaborate and influence across multiple, cross-functional teams Strong communication skills (verbal and written) Hands-on approach to product development/improvement Preferred qualifications: Comfort with self-directed work in addition to collaboration in a team environment Experience with design changes, complaint reduction, and corrective action Strong ability to successfully multi-task and adapt
Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): 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. About the Role
We have an exciting opportunity to join the Design Quality team supporting the TheraSphere Y90 device. TheraSphere is a catheter-based, loco-regional radiation therapy. In this role, you will make important contributions to exciting new applications (TDP) and excel in a dynamic, fast-paced environment. This Design Quality Engineer II will work with high-performing cross-functional development teams to develop and maintain the design control deliverables, risk management analysis, and DHF compliance to ensure delivery of the highest quality product to the customer. Boston Scientific values 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:
Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing input. Understand clinical use cases and user interface requirements to drive design decisions and implement through the risk management package. Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) Collaborate with R&D to ensure the design of test assemblies and test method parameters using current analysis techniques and technologies will allow for success in test method validation. Independently drive the test method validation process as well. Monitor field performance against risk assessments. Analyze these data and identify areas of product design to proactively improve field performance. Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed. May include design and execution of structured experimental plans to drive data-based decisions informing the proposed change decision. Support the verification, validation, and usability testing to meet or exceed internal and external requirements. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. What We're Looking For In You:
Required qualifications: Bachelor's degree in an Engineering discipline 2+ 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 use of Quality tools/methodologies Ability to collaborate and influence across multiple, cross-functional teams Strong communication skills (verbal and written) Hands-on approach to product development/improvement Preferred qualifications: Comfort with self-directed work in addition to collaboration in a team environment Experience with design changes, complaint reduction, and corrective action Strong ability to successfully multi-task and adapt