Boston Scientific-posted about 1 month ago
$69,500 - $132,000/Yr
Full-time • Mid Level
Hybrid • Maple Grove, MN
5,001-10,000 employees
Merchant Wholesalers, Durable Goods

We have an exciting opportunity for Design Quality Engineer II supporting single use devices and/or capital equipment within the BSC's Interventional Cardiology/Vascular division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and sustaining engineering experience. In a hybrid work mode, the Design Quality Engineer II will support a team of engineers to apply the directives of design controls to projects such as design changes, regulatory and standards compliance, corrective and preventive actions, improvements for manufacturability, and cost-reduction efforts. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Develops and executes plans for design control and risk management of complex projects
  • Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
  • Working knowledge of Design Controls. Provide design quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
  • Promotes and influences compliance to BSC's quality, business and health & safety systems and market/legal regulations
  • Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure.
  • Bachelor's degree in engineering or science discipline, or equivalent.
  • 3+ years experience in design assurance, quality, or related medical device or regulated industry experience
  • Knowledge of basic Quality System Requirements and Good Documentation Practices
  • High energy problem solver capable of driving items to closure.
  • Adaptable and effective collaborator in a team environment and in self-directed work
  • Strong communication skills (verbal & written)
  • Experience with Class III Medical Devices
  • Experience with Capital Equipment
  • Experience with design control, risk management, and medical device standards compliance
  • Experience with corrective and preventive action
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