Senior Design Quality Engineer - Urology

bostonscientific•Minnetonka, MN

2d•$82,600 - $156,900•Hybrid

About The Position

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 open for a Senior Design Quality Engineer who will support our sustaining Prosthetic Urology franchise. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls supporting product development, design changes, regulatory and standards compliance, corrective and preventive actions, identifying improvements for manufacturability and cost-reduction efforts. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Minnetonka, MN and requires being on-site at least three days per week. This position will start off at our Minnetonka, MN facility but will be transferred to our Maple Grove, MN sometime in 2026.

Requirements

Bachelor’s degree in chemical engineering, Biomedical Engineering, or related engineering field
5+ years of experience in design assurance, quality, new product development, or sustaining related medical device / regulated industry experience
Detailed understanding of US and International regulations including 21 CFR 820 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
Independently leads quality deliverables and supports decision-making with little supervision
Adaptable and effective collaborator in a team environment and in self-directed work
Strong communication skills (verbal & written)

Nice To Haves

Demonstrated use of Quality tools/methodologies
Experience with pharma/combination devices with working understanding of US regulations including 21 CFR, 210, 211, and 11 is preferred.

Responsibilities

Support the execution and documentation of Design Validation & Verification and Usability activities
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
Own and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
Good knowledge of Design Controls.
Provide quality and compliance input 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, SW Validation, Process Validation and Labeling).
Lead and support cross-functional root-cause analysis investigation and resolution activities.
Leads/provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Directly interfaces with internal and external audit activities
Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
Support regulatory submissions to notified bodies.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.