Principal Quality Assurance Engineer

2 weeks ago

Coralville, Iowa, United States Danaher Corporation Full time
Job Title: Principal Quality Assurance Engineer

Integrated DNA Technologies (IDT) is a leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions.

We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team. At IDT, we realize that although science may be uniform, people are unique.

This position is part of the Regulatory Affairs and Compliance Department and will be onsite based in Coralville, IA. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive.

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.
  • 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.
  • 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.
  • Audit, identify and support implementation of Design process improvements and act as resource for colleagues in explaining design control and risk management concepts and requirements.
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.

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

At Danaher Corporation, we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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