Design QA Engineer III

Recruiter: Spencer Gregory Hale

Design QA Engineer III 

Boston Scientific is a worldwide and diverse company who puts patients first. As an industry leader in kidney stone management, the Urology divisional team is on a mission to provide urologists with products that offer the best quality, functionality, and flexibility he/she/they need to treat their patients.

About the role: 

As a Design Quality Assurance Engineer III, you’ll be at the heart of that mission by working with high-performing cross-functional teams to primarily sustain commercialized BPH products, including medical electrical systems (MES) and single use device (SUD). He/she/they will serve as a Quality representative who can directly impact patient care by ensuring the safety, quality, post market performance and compliance of the prostate health franchise products are maintained while continuously improving their value. He/she/they will interface with cross-functional teams to complete sustaining projects, design control deliverables, and activities to ensure our products continue to meet state of the art regulatory standards and user needs.

Your responsibilities will include: 

• Effectively works with and influences cross-functional teams during the Design Change process to ensure proposed changes to products are systemically / thoroughly analyzed, assessed, controlled and implemented appropriately (i.e., EN 13485 / CFR820).
• Support Risk Management planning, updating and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (eg. EN 14971).     
• Support Usability Engineering and planning documentation (eg. EN 62366/ISO 62366) 
• Interface with the core team and support the sustaining effort for both product and packaging designs. 
• Interface with the core team and support manufacturing operation efforts / changes to ensure they meet or exceed internal and external requirements.
• Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues. 
• Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals.
• Support internal and external regulatory audits as required.

What we’re looking for in you: 

Required Qualifications

• Minimum of a BS in Engineering (Biomedical, Electrical, Software or equivalent).  
• Minimum of 3-6 years of related experience.  
• Travel approximately <10%
• In depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design & development and product risk management.  
• Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork.
• Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.  
• High energy problem solver capable of driving items to closure.  
• Strong communication (oral and written) and presentation skills.  
• Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).  

 Requisition ID: 580984

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.