Design Assurance Engineer

1 week ago

Maple Grove, United States Apex Systems Full time

We have an exciting opportunity for a Design Quality (or Design Assurance) Engineer supporting percutaneous coronary intervention (PCI) single use devices (SUD) within the Interventional Cardiology (IC) division.


This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and product development experience.


This role will apply the directives of design controls supporting product development, design changes, regulatory and standards compliance, corrective and preventive actions, identifying 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.


Responsibilities

  • Support the execution and documentation of Design Validation & Verification and Usability activities.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
  • Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
  • Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Lead and support cross-functional root-cause analysis investigation and resolution activities
  • Evaluate and support design test and inspection method development, and lead method validation activities
  • Support regulatory submissions to notified bodies.
  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.


Minimum Qualifications

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related field of study
  • Prefer 3-6+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
  • Will consider less than 3 years of experience based on candidate ability.
  • Problem solver, capable of facilitating the problem-solving process
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Demonstrated use of Quality tools/methodologies (CAPA/Root Cause)

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