Job Description

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:

Great opportunity to be part of a fast-paced highly reputable medical device company developing lifesaving therapy. The Quality Engineering II provides focused quality engineering support within new product development and/or post-market, sustaining activities

Your responsibilities will include:

• Working closely with a cross-functional team (R&D, Manufacturing, Supplier, Regulatory Affairs, Marketing etc.) to provide input on project decisions with a quality-first mindset
• Executing design controls deliverables for medical device hardware and software systems
• Developing and/or providing feedback on Design Inputs, Outputs, Verification and Validation protocols and reports, Risk Analysis (Hazard Analysis, DFMEA), Usability, Cybersecurity, Design Transfer
• Maintaining product risk management files, Design History Files
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving product quality issues. Investigating and resolving complaint trends. Driving investigation and solution implementation for CAPAs
• Generating periodic post market surveillance reports
• Supporting quality system initiatives
• In all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Boston Scientific Quality Policy and all other documented quality processes and procedures.

Required qualifications:

• Bachelor\'s Degree in Biomedical Engineering or related engineering discipline
• Minimum 3 years of experience in medical device industry
• Excellent communication skills; fluent English (oral & written), working French

Preferred qualifications:

• Advanced degree in engineering, engineering management, or related field
• Previous experience in medical device design quality
• Previous experience with medical device software development and validation
• Previous experience in hardware systems development and validation
• Ability to work in a fast paced, dynamic environment

Requisition ID: 560267

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn\'t just business, it\'s personal. And if you\'re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Boston Scientific