Design Quality Assurance Engineer II

Boston Scientific
Boston Scientific

Offre publiée le 2022-11-19

About the role :

Great opportunity to be part of a fast-paced highly reputable medical device company developing lifesaving therapy. The Design Quality Engineer 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 of 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 : 544382