Senior Design Quality Engineer

Overview

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: 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 Thera Sphere 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.

In line with our collaboration ethos, 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.

• 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 systematically 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.

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.

Requisition : 614570

Salary: Minimum $82,600 – Maximum $156,900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on actual location of the position and other pertinent factors. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for…