Job Summary

The Design Assurance Engineer will support development projects as a quality core
team member, actively participating in project teams by planning, coordinating and
performing engineering actions for the project.

Essential Responsibilities:

  • Define and/or recommend design inputs and design outputs.
  • Partner with Customer to identify and manage product risk throughout the
    development process and sustaining efforts with the use of risk management
    plans/reports, risk assessments, FMECA, and other risk management tools.
  • Establish and implement methods and procedures for inspecting, testing and evaluating
    components and products.
  • Participate in product development process activities such as design characterization,
    design verification, design validation, process validation, regulatory submissions and
    other activities as needed.
  • Partner with manufacturing and external suppliers to review and assess any design or
    process changes that may impact the product specifications or overall performance.
  • Resolve product performance issues (NCMRs, CAPAs, deviations, manufacturing process
    problems etc.) with the Customer and cross-functional team members to impact on
    product safety, performance and quality.

Education, Experience and Other Skills

  • Bachelor’s degree with at least 7 years in medical device manufacturing and design
  • Experience in product development and design controls.
  • Practical knowledge of FDA Quality System Regulations, ISO 13485 and EU Medical
    Device Regulation.
  • Practical knowledge of ISO 14971, EN 45502, IEC 60601-1, and other product and
    testing standards.
  • General familiarity with industry best practices in electrical, mechanical, testing and
    sterilization processes.
  • Skilled in standard statistical methods e.g. DOE, sampling plans and measurement
    system analysis.

Mental and Physical Requirements

  • Ability to handle and be trusted with confidential and/or sensitive information.
  • Ability to work in a fast-paced, constantly changing environment.
  • Ability to be flexible and to handle multiple projects in an organized, timely manner.
  • Ability to problem-solve, work under pressure, and to effectively manage stress.