Medical Device Design Assurance Engineer

1 month ago

Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full time
About the Role:

The Design Assurance Engineer is a key member of our cross-functional team, responsible for ensuring the safety, quality, and compliance of our medical device products from concept to commercialization. This role requires a strong understanding of design controls, risk analysis, and quality system regulations.

Your Responsibilities:
  • Develop and implement test methods and equipment to satisfy product requirements.
  • Write technical documentation for procedure execution, technical rationale, and evidence of the development process.
  • Support development and coordinate the execution of Design Validation and Verification activities.
  • Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
  • Mentor cross-functional team members through the product development process, specifically with respect to design control and risk management deliverables.
Required Qualifications:
  • Bachelor's degree in Biomedical or Mechanical Engineering or related field of study.
  • 3+ years of experience in design assurance, new product development, or related medical device / regulated industry experience.
  • Self-motivated with a passion for solving problems and a bias for action.
  • Hands-on approach to product development.
  • Experience using Solidworks 3D Modeling Software or equivalent.
  • Demonstrated use of Quality tools/methodologies.
  • ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
  • Travel as required (10%).
Preferred Qualifications:
  • Previous development of testing and/or automated equipment.
  • Previous experience with Measurements System Analysis.
  • Experience integrating data acquisition equipment and clinically relevant simulated environments.
  • Experience using Minitab statistical software.
  • Experience using Matlab programming language.

Boston Scientific Corporation is an equal opportunity employer and maintains a prohibited substance-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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