Design Controls Specialist

6 days ago


Mississauga, Ontario, Canada Boston Scientific Gruppe Full time
About the Role:
We are seeking a Senior Design Assurance Engineer to join our Design Assurance team. This position works closely with New Product Development and Product Life Cycle teams to ensure risk management is applied, adequate design controls are met, and subsequent production and process controls are adequate. This position will focus on Design Assurance for packaging and labeling for single use medical devices, capital equipment, and accessories.

Your Responsibilities:
Your responsibilities will include:
  • Serving as an effective quality leader or team member on multiple cross-functional product development teams and/or product sustaining teams.
  • Promoting the culture of quality-centric patient care and customer satisfaction within projects and teams.
  • Supporting junior team members by setting an example, coaching and providing feedback and guidance.
  • Independently, or as a member of a team, developing, directing and executing plans for design control and risk management of complex projects.
  • Providing 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).
  • Leading the development, implementation, and maintenance of product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.
  • Using clinical knowledge/data to influence how packaging is tested and designed.
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Demonstrating good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
  • Identifying and driving continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.


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