Are you ready to work for a Pre-IPO startup looking to change healthcare as we know it?
We're currently seeking a Senior Design Quality Engineer who can work in a fast-paced environment in a high impact, high visibility role. You will lead the software design quality for their products and actively manage the design controls and DHF.
So, what are the key responsibilities?
- Own Design History Files for (DHF) for software development projects for medical device software products (SaMD) for legacy and new products
- Serve as design controls (21 CFR 820.30) SME for Pear group
- In conjunction with the technical team, develop and organize design documentation including user needs, software requirements specifications, design specifications, verification/ validation plans and protocols, and risk management
- Lead and perform risk management activities for software products
- Represent the Quality function in all software development core teams
- Lead design reviews
- Lead design change assessment and configuration management with Product teams
- Support other QMS areas including NC, CAPA, complaints, management reviews and others, as needed
- Represent design quality in meetings with regulators (like FDA), Customers, investors and other important stakeholders
- Updates to QMS documentation, as needed.
What are the requirements?
Expertise in medical device Quality Management System regulations and standards including ISO 13485 and 21 CFR 820 (knowledge of 21 CFR 210/211 desirable), with a focus on 21 CFR 820.30 Design Controls
Thorough knowledge and understanding of EN ISO 14971 and other risk management practices
Familiarity with software development, including Agile methodologies
Extensive knowledge of quality tools and APIs (including enterprise QMS systems)
Must be able to think in an Agile framework and know how to extract useful design outputs/ artifacts in collaboration with software development engineers. It is critical to understand how design controls is implemented in an Agile company.
Sthree US is acting as an Employment Agency in relation to this vacancy.