Integrated DNA Technologies (IDT) is the 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. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.
IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
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. Together, we accomplish great things.
In this role, you will have the opportunity to:
- 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 and as the Design Assurance representative on cross-functional team 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. and completes documentation and deliverables as required.
- 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; includes assisting technical teams in the assessment of design changes; including assessment, planning, verification and validation of the change and documentation, including appropriate selection of acceptance criteria and sampling plans, as required.
- 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; may include coaching and developing proficiency in the use of design control and risk management principals/processes to establish the best approaches to problems.
The essential requirements of the job include:
- 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.
It would be a plus if you also possess previous experience in:
- software design and development process following 62304 guidance (highly preferred).
- 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.
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