Senior Design Assurance Engineer

1 month ago


Mississauga, Ontario, Canada Boston Scientific Full time
About the Role

Boston Scientific is seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. As a key member of our team, you will be responsible for ensuring adequate design controls are met and subsequent production and process controls are adequate for our next-generation capital equipment devices.

Responsibilities
  • Responsible for design control and risk management of next-generation capital equipment devices.
  • Uses clinical knowledge to influence how devices they are working on are tested and designed.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects.
  • Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
  • Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team.
  • Promotes and influences compliance to BSC's quality, business and health & safety systems and market/legal regulations.
  • Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines).
Requirements
  • Bachelor's Degree in Engineering (Electrical Engineering and/or Systems Engineering highly preferred).
  • 5+ years of relevant work experience.
  • Knowledge of ISO 13485, ISO 14971, IEC 62366-1.
  • Experience with design controls, design inputs and outputs, and risk mitigation activities.
  • Experience with systems and electrical/software design and test experience with IEC 60601-1 and collateral standards.
  • Excellent analytical and communication skills (written and oral).
  • Excellent organization and time management skills.
  • Interest in biomedical or health-related industry.
Preferred Qualifications
  • 2+ years of experience in a Design Assurance role.
  • 5+ years of experience in the medical device industry.


  • Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full time

    Senior Design Assurance EngineerBaylis Medical Technologies Inc. is seeking a highly skilled Senior Design Assurance Engineer to join our Quality Engineering team. As a key member of our team, you will be responsible for ensuring the quality and safety of our medical devices.Key Responsibilities:Develop and implement design controls to ensure compliance with...


  • Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full time

    Senior Design Assurance EngineerBaylis Medical Technologies Inc. is seeking a highly skilled Senior Design Assurance Engineer to join our Quality Engineering team. As a key member of our team, you will be responsible for ensuring the quality and safety of our medical devices.Key Responsibilities:Develop and implement design controls to ensure compliance with...


  • Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full time

    Senior Design Assurance EngineerBaylis Medical Technologies is seeking a Senior Design Assurance Engineer to join our Quality Engineering team. This role requires a deep understanding of design controls, risk management, and usability engineering within the medical device industry.Key Responsibilities:Ensure the effectiveness of design controls activities...


  • Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full time

    Job Title: Senior Design Assurance EngineerBaylis Medical Technologies Inc. is seeking a highly skilled Senior Design Assurance Engineer to join our Quality Engineering team. As a Senior Design Assurance Engineer, you will be responsible for ensuring the effectiveness of design controls activities for New Product Introduction (NPI) projects, ensuring...


  • Mississauga, Ontario, Canada Baylis Medical Technologies Inc. Full time

    Job Title: Senior Design Assurance EngineerBaylis Medical Technologies Inc. is seeking a highly skilled Senior Design Assurance Engineer to join our Quality Engineering team. As a Senior Design Assurance Engineer, you will be responsible for ensuring the effectiveness of design controls activities for New Product Introduction (NPI) projects, ensuring...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This role will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This role will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. In this role, you will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. In this role, you will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This role will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This role will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. In this role, you will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. In this role, you will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. As a key member of our team, you will work closely with Medical Electrical Equipment/Capital Equipment new product introduction and product life cycle teams to ensure adequate design controls are met and subsequent production and process...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This position plays a critical role in ensuring the adequacy of design controls and subsequent production and process controls for novel electrophysiology devices.Key ResponsibilitiesDevelop and execute plans for design control and risk...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This position plays a critical role in ensuring the adequacy of design controls and subsequent production and process controls for novel electrophysiology devices.Key ResponsibilitiesDevelop and execute plans for design control and risk...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This position plays a critical role in ensuring the adequacy of design controls and subsequent production and process controls for novel electrophysiology devices.Key ResponsibilitiesDevelop and execute plans for design control and risk...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This position plays a critical role in ensuring the adequacy of design controls and subsequent production and process controls for novel electrophysiology devices.Key ResponsibilitiesDevelop and execute plans for design control and risk...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This position plays a critical role in ensuring the adequacy of design controls and production processes for novel electrophysiology devices.Key ResponsibilitiesDevelop and execute plans for design control and risk management of complex...


  • Mississauga, Ontario, Canada Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. This position plays a critical role in ensuring the adequacy of design controls and production processes for novel electrophysiology devices.Key ResponsibilitiesDevelop and execute plans for design control and risk management of complex...