Principal Quality Engineer

2 weeks ago


Coralville, Iowa, United States Danaher Corporation Full time
Job Title: Principal Quality Engineer - Design Assurance and Risk Management

We are seeking a highly skilled Principal Quality Engineer to join our Regulatory Affairs and Compliance Department. As a key member of our team, you will be responsible for ensuring the quality and compliance of our medical devices.

Key Responsibilities:
  • Support all phases of product development, including software as a medical device, through design controls, risk management, usability, systems engineering, architecture, design verification and design validation.
  • Ensure compliance of these activities with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.
  • Work closely with Regulatory Affairs in preparation of global regulatory submissions, including FDA pre-submissions, 510k, IVDR CE certifications technical files, etc.
  • Facilitate and participate in product risk management process supporting documentation compliant with ISO 14971 such as hazard analysis, FMEAs, risk assessments, etc.
  • Work independently and with project team members to develop and improve product and processes to reduce variability and increase robustness throughout the development cycle for multiple projects.
Requirements:
  • Bachelor's degree in science, medical, or technical field required.
  • Minimum of 7 years of experience supporting design controls related to development of regulated medical devices with integrated software or software as a medical device required.
  • Strong working knowledge of ISO 13485, 21 CFR 820 and ISO 14971 required.
  • Demonstrated understanding of technical/scientific principles that relate to multiple and diverse product lines or manufacturing processes.
  • Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat.
Preferred Qualifications:
  • Software design and development process following 62304 guidance.
  • Experimental design and assay development process.
  • Identifying, analyzing and mitigating risk.
About Us:

Danaher Corporation is a global leader in the life sciences and diagnostics industries. We are committed to equal opportunity and diversity in the workplace.

We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees.



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