Design Quality Engineer II

Additional Locations:  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:

This position provides an exciting opportunity to work for a worldwide and diverse company who puts patients first. The Design Assurance Quality Eng II will provide quality engineering support to products in the Endoscopy division working alongside a high-performing cross functional team, applying problem-solving, critical thinking and risk management skills to ensure product safety and performance.

Design Quality Assurance (DQA) acts as the quality representative from a design perspective, responsible for design controls and risk management of products to ensure safety and compliance with internal procedures and regulations. In sustaining, DQA collaborates with multiple functions: R&D, Regulatory Affairs, Marketing, Medical Safety, Operations (Manufacturing, Quality, Production) and others to support initiatives for existing products on the market, such as: design changes, preventive / corrective actions and cost reduction initiatives.

Your responsibilities include:

• Contributing to all aspects of Design Quality Assurance activities in an FDA/EU MDR regulated environment.
• Working within a cross functional team of Sustaining Engineers and Specialists such as: R&D, Regulatory Affairs, Marketing, Medical Safety, Manufacturing, Quality, Production and others.
• Supporting the design, development, and test of finished devices and accessories in the Boston Scientific Endoscopy division during their development life cycle, focused on sustaining existing products on the market.
• 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 and Labeling).
• Participate in product, system, and sub-system level design changes with focus on device design evaluation, design controls, product risk mitigation, and other risk management activities.

• Champion compliance to company policies, work instructions and SOPs.

• Support the creation, review and maintaining of risk management documentation such as: Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA), Fault Tree Analysis (FTA) and Usability Engineering documentation.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e 5 Whys Analysis, Is-Is Not Analysis, Cause and Effect Analysis and DMAIC problem solving methodologies).
• Participating in Value Improvement Projects (VIPs), cost reduction initiatives such as: new suppliers, alternate materials, design changes, etc.
• Support DQA activities during internal and external audits, as needed.
• May perform other duties as directed

What we’re looking for in you:

Minimum Qualifications

• BS in Biomedical, Mechanical Engineering, or related technical discipline.
• Minimum of 2 years of medical device or related engineering experience.
• Fluent in English and Spanish.
• Strong communication and presentation skills.
• Problem solving and critical thinking skills.
• Competent with use of Microsoft Office Suite and Minitab statistical analysis software (or equivalent).
• Ability to collaborate and work in a global team.
• Position located in Coyol, Costa Rica.
• Willing / able to travel approximately <10% of the time. 

Preferred Qualifications

• 2+ years of medical device engineering experience.

• Knowledge in Design Controls, Risk Management and Usability for Medical Devices

• Familiar with FDA QSR, EN ISO 13485, EN ISO 14971, and IEC 60601 regulations and standards.

Requisition ID: 636206

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.