Design Quality Assurance Engineer II - Urology

Design Quality Assurance Engineer II - Urology

Onsite Location(s):
Marlborough, MA, US, 01752

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.

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 they need to treat their patients. As a Design Quality Assurance Engineer II, you’ll be at the heart of that mission by working with high-performing cross-functional teams to primarily sustain commercialized Visualization products, including medical electrical systems (MES).

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 visualization 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.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three days per week.

Relocation assistance is available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Act as an effective cross-functional team member in supporting quality disciplines, decisions, and practices.
• 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 / CFR
  820).
• Support planning, updating and maintenance of product Risk Management documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (i.e., EN 14971).
• Support Usability Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 60601-1-6).
• 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 in a timely manner.
• 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.

Required Qualifications:

• Minimum of a Bachelor’s Degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
• Minimum of 2 years of related experience.
• Travel approximately < 10%

Preferred Qualifications:

• Experience in the Medical Device industry (quality and risk management) and medical electrical systems.
• Detailed understanding of ISO 13485, ISO 14971, and Quality System Regulations.
• Skillful problem solver, capable of facilitating the problem-solving process and driving to solutions in a timely manner.
• Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork.

Requisition

Minimum Salary: $75,100

Maximum Salary: $142,600

The anticipated compensation listed above and the…