Sr Quality Engineer- Design Assurance
Danaher
- Coralville, IA
- Permanent
- Full-time
- Participate in cross-functional teams at various phases of the development cycle as the Quality Engineering representative.
- Supports development of products, 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 on deliverables for global regulatory submissions, including FDA pre-submissions, 510k and IVDR CE certifications.
- Participates in product risk management process supporting documentation compliant with ISO 14971 such as hazard analysis, FMEAs, risk assessments, etc.
- Works independently with moderate guidance 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
- Assists technical teams in the assessment of design changes; including assessment, planning, verification and validation of the change and documentation as required.
- Performs other duties as assigned.
- Bachelor’s degree in science, medical, or technical field required.
- Minimum of 3 years of experience supporting design controls related to development of regulated medical devices with integrated software 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.
- Experience with software as a medical device preferred.
- Experiences in experimental design and assay development process is highly preferred.