Staff SW Quality Assurance Engineer responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system.
Requirements
- BS degree in computer science, computer engineering or equivalent field. Master’s degree preferred.
- Experience with medical device software development. Cloud software in medical device preferred.
- Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW Tools.
- Experience with software mobile applications, cloud-based systems, and cybersecurity.
- A minimum of 8 years work experience in Software Quality Engineering within an FDA, ISO, or other regulated environment and/or equivalent combination of education and experience.
- Experience in the development and implementation of effective Design Control Systems.
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
- Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for 510(k).
- Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
- Experience with software development lifecycles with emphasis on the software quality engineering aspects.
- Effective verbal and written communication skills.
- Experience collaborating and communicating with individuals at multiple levels in an organization.
- Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
- Strong analytical and problem-solving skills.
- Able to work effectively in a high-stress, high-energy environment.
- Ability to influence people and projects in a fast-moving environment.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- Additional employee wellness programs
