Senior Design Assurance Engineer - Software
Are you looking for a Software Design Assurance role in a growing industry? Our client in the Medical manufacturing space is seeking a Sr Design Assurance Engineer to join their growing team in the West metro area. This is a long term contract role.
Responsibilities of the Sr Design Assurance Engineer:
- Perform Design Assurance engineering work requiring full competency in software and/or embedded software engineering.
- Plans and conducts design assurance activities related to software lifecycle processes compliant with EN/IEC 62304; works closely with product development engineering to establish new approaches to problems as encountered.
- Actively participates in software development planning to ensure design verification and validation activities conform to established product requirements and sound testing principles.
- Routinely provides Design Assurance guidance and direction to engineers/technicians on the project assignment.
- Conducts Design Assurance engineering activities of significant scope or degree of difficulty (medium-large component/system/process associated with a medium to large project).
Qualifications of the Sr Design Assurance Engineer:
- Bachelor's degree with 5-8 years experience. Preferred in Software Engineering / Computer Engineering or equivalent; with seven to ten years' professional level experience within the medical, or a closely related industry, is required.
- Knowledge and skill in software engineering documentation procedures, development methods and project management, with the ability to rapidly master internal procedure and methods, such as Documentation System, ECOs, DVTs, etc.
- Depth of knowledge of applicable QSSOPs, regulations, and standards etc. with proven skill in integrating into software engineering discipline.
- In depth knowledge of ISO 13485, ISO 14971, 21 CFR 820 Design Controls, and EN/IEC 62304