Boston Scientific Gruppe
Senior Design Quality Engineer
Boston Scientific Gruppe, Osseo, Minnesota, United States, 55311
Overview
At Boston Scientific, we value Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance. We’ll give you the opportunity to work in teams of diverse, high-performing employees, tackle important health industry challenges, and advance your skills and career in a collaborative environment. This role follows a hybrid work model requiring the employee to be in a 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. About the role
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. Relocation assistance may be available. This role is based in a hybrid work environment with in-office requirements as noted. Your responsibilities
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 proposed changes are systematically analyzed and assessed. Updates and maintains product risk management tools (e.g., 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 and 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 qualifications: 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 Knowledge of 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 multi-task and adapt Comfort speaking to groups; presentation skills to translate performance and issues to peer and senior management audiences Requisition ID:
614570 Minimum Salary:
$82,600 Maximum Salary:
$156,900 The anticipated compensation and benefits offered by Boston Scientific will vary based on location and other factors. Compensation will be commensurate with experience, education, and credentials. Boston Scientific is an equal opportunity employer. Compensation for non-exempt (hourly), non-sales roles may include variable compensation and annual bonus targets. Compensation for exempt, non-sales roles may include variable compensation, annual bonuses, and long-term incentives, subject to plan eligibility and other requirements. For certain US-based positions, including field sales and service roles that interact with hospitals and healthcare centers, acceptable proof of COVID-19 vaccination status may be required. The company will communicate any such requirements during the interview process and will comply with applicable laws and policies. This role is safety-sensitive and may be subject to a prohibited substance test as required by applicable law. Nearest Major Market:
Minneapolis Job Segment:
Senior Quality Engineer, Medical Device Engineer, Design Engineer, Quality Engineer, Medical Device, Engineering, Healthcare
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At Boston Scientific, we value Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance. We’ll give you the opportunity to work in teams of diverse, high-performing employees, tackle important health industry challenges, and advance your skills and career in a collaborative environment. This role follows a hybrid work model requiring the employee to be in a 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. About the role
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. Relocation assistance may be available. This role is based in a hybrid work environment with in-office requirements as noted. Your responsibilities
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 proposed changes are systematically analyzed and assessed. Updates and maintains product risk management tools (e.g., 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 and 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 qualifications: 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 Knowledge of 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 multi-task and adapt Comfort speaking to groups; presentation skills to translate performance and issues to peer and senior management audiences Requisition ID:
614570 Minimum Salary:
$82,600 Maximum Salary:
$156,900 The anticipated compensation and benefits offered by Boston Scientific will vary based on location and other factors. Compensation will be commensurate with experience, education, and credentials. Boston Scientific is an equal opportunity employer. Compensation for non-exempt (hourly), non-sales roles may include variable compensation and annual bonus targets. Compensation for exempt, non-sales roles may include variable compensation, annual bonuses, and long-term incentives, subject to plan eligibility and other requirements. For certain US-based positions, including field sales and service roles that interact with hospitals and healthcare centers, acceptable proof of COVID-19 vaccination status may be required. The company will communicate any such requirements during the interview process and will comply with applicable laws and policies. This role is safety-sensitive and may be subject to a prohibited substance test as required by applicable law. Nearest Major Market:
Minneapolis Job Segment:
Senior Quality Engineer, Medical Device Engineer, Design Engineer, Quality Engineer, Medical Device, Engineering, Healthcare
#J-18808-Ljbffr