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We are searching for a Senior Design Quality Engineer for a rapidly growing medical devices company. This well funded company has a strong pipeline of electromechanical medical devices in various development stages.
The ideal candidate for Senior Design Quality Engineer will have a strong background in design fundamentals, has worked in both large and small companies, and thrives in an environment working on a variety of projects, not one line or product. Flexibility is key to his role, as is a desire to contribute to the larger good, not simply checking the boxes of your own projects or assignments.
Candidates at different levels in their careers will be considered based on experience.
Requirements for the Senior Design Quality Engineer:

  • Bachelor’s Degree in Engineering or Scientific related field

  • 4+ years of Quality Engineering, Quality Manufacturing, and/or R&D experience

  • Hands-on experience with Design Assurance, including Design Controls, Design Freeze (or pre- design freeze feasibility testing), Design Verification & Validation, and/or Design Test Method Development.

  • Experience working within a highly regulated industry.

  • Working knowledge of Software Development Life Cycle Processes in accordance with IEC 62304, highly preferred.

  • Working knowledge of Usability Engineering Processes in accordance with IEC 62366, highly preferred.
  • Experience leading design assurance and development activities which could include engineering studies, feasibility testing, drawing reviews for new product development programs.
Responsibilities of the Senior Design Quality Engineer:
  • Leadership role in the creation and maintenance of risk management files in accordance with ISO 14971 and applicable regulations (plans, hazard analyses, FMEAs, software hazard analysis, reports, etc.)
  • Develop QA specifications, test methods, inspection procedures, sampling plans, and related written procedures.
  • Lead test method development and validation activities.
  • Support new product launch, master validation plans, product V&V, process validations, and design transfer into manufacturing.
  • Daily support of production requirements and issues through active involvement and presence in the assembly operations.
  • Continual improvement of methods and systems towards full compliance and world class manufacturing.
  • Implement and review changes to existing products, SOPs, Work Instructions, Test Methods, Process Changes, Design Changes, Labeling, and Field Issues to define the requirements for regulatory submissions and notifications.
  • Support and prepare documentation for regulatory submissions and worldwide registrations

Occupational Category: 17-2199 Engineers, All Other

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