- 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.
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Sr Quality Engineer- Design Assurance - Boulder, United States - Danaher Corporation
Description
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 located in Coralville, IA and will be hybrid. 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:
The salary range for this role is $80, $90, This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
#LI-LCS
At Danaher 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here ) .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
