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Boston Scientific · 1 day ago

Senior Design Quality Engineer - Urology

Minnetonka, MN - AMS

Full-time

Hybrid

Mid, Senior Level

$83K/yr - $157K/yr

5+ years exp

Boston Scientific is a leader in medical science committed to solving important health challenges. The Senior Design Quality Engineer will support the Prosthetic Urology franchise, focusing on product development, regulatory compliance, and ensuring patient safety.

Health CareMedicalMedical Device

No H1B

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

Qualification

Design ControlsQuality AssuranceRisk ManagementRegulatory ComplianceBiomedical EngineeringQuality ToolsMedical Device ExperienceProblem-SolvingCommunication SkillsCollaboration

Required

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)