Verification & Validation Engineer
920 Winter St Greater Boston Area, Massachusetts
Position: Verification & Validation Engineer
Location: Greater Boston Area
Type: Contract or Direct Hire
Interview: Phone and In Person
Required: V&V, medical, FDA
Principal duties and responsibilities:
- The software development team at Global Digital Solutions (GDS) is chartered with building ConnectedHealth platform that allows deep data integration of kidney dialysis products with patient care systems to help clinicians improve patient care globally. The SW V&V Engineer will be working on new and continuing software development projects throughout the GDS medical software space.
- The diversity and complexity of the development work ranges from design, development and implementation of embedded systems, IoT solutions, multi-tenant clinician portals, integration with external EHR system and mobile applications. All are accomplished within the context of medical software space.
- The primary area of focus for this person would be to function as a leader to design, develop and modify software verification and validation plans that meet the rigorous requirements of a medical software system.
- Define requirements, develop protocols and reports for V&V activity across multiple projects by analyzing software requirements and following the appropriate software development procedures. The objective being to deliver evidence to demonstrate the safety and efficacy of the software solutions in a consistent manner.
- The role may also include managing execution of test protocols, and generating reports to describe program evaluation, testing, and correction.
- Ensure that all test protocols adhere to best practices as well as compliance with internal SOPs and FDA/industry regulations.
- Mentor local and off-shore team members in following quality procedures and creating quality documentation.
Bachelor’ s Degree in an engineering or related discipline is required. Advanced degree preferred.
Experience and required skills
- Over 5 years of experience as a V&V engineer with expertise in validation methodologies, technical writing and quality assurance in the medical device software arena.
- Firsthand experience with validating web applications for FDA Quality Systems Regulations would be very desirable
- Expert in Computer System Validation process in a highly regulated health and safety related environment.
- Expertise in the knowledge and use of key regulations and standards such as 21 CFR 11/820, ISO-13485/14971, IEC-62304/60601 etc.
- Expertise in using test and defect management tools such as TestRail, HP Quality Center, TFS, Jira etc.
- Expert in producing high quality documentation with a strong attention to detail.
- Proficient in creating V&V team plans that span contributors across multiple organizations that are globally distributed.
- Proficient with Rapid Applications Development principles and modern and traditional software development methodologies
- Proficient with HL7, C-CDA and other common healthcare protocols. Familiarity with FHIR is preferred.
- Proficient with HIPAA requirements. Familiarity with GDPR is preferred
- Familiarity with GAMP4 and GAMP5 practices.
- Excellent team player with great analytical, interpersonal and written communication skills.