REQUIRED EDUCATION: Bachelor’s degree in EC/Biomedical engineering
KEY RESPONSIBILITIES: • Review product, user and technical system requirements for completeness, feasibility, and testability of the product and/or system
- Define and implement system integration and test protocols
(including embedded, mobile and web services software, as well as electrical and mechanical systems)
- Design and develop repeatable test methods/procedures and automated scripts for product & system verification, considering both requirements-based and clinical and business use case-based approaches
- Define and implement system verification and validation protocols, sampling rationale and acceptance criteria in coordination with engineering and research teams, and create associated documentation (plans, protocols, and reports) that comply with US and international medical device regulations and corporate quality management systems procedures
- Plan, develop and execute test protocols to ensure product safety and effectiveness appropriate to the stage of development for the device, encompassing software, hardware, and system level components
- Continually “stress test” and use the device(s)
to identify design and/or manufacturing issues prior to product release
- Assist in the design and implementation of proof-of-concept simulations and/or prototypes
- Contribute to error budgeting, reliability analysis, design for manufacturability, and design for cost programs
- Assists in writing and coordinating the submission of Regulatory documents to FDA and other Regulatory Agencies, including
International Documents (e.g., technical files)
- Work within timelines, resources, and budgets for completion of assigned projects
- Provides technical leadership on various engineering projects and/or sub-projects
- Plan and implement process improvements within the V&V; functions
- Other tasks and responsibilities as assigned
SKILLS &
RESPONSIBILITIES
- Bachelor’s degree in EC/Biomedical engineering /EEE
- Minimum 4 years of experience
- Experience with medical devices performing real-time data acquisition
- Experience in medical device verification and validation
- Excellent oral, written and presentation skills
- Knowledge of basic statistics
- Excellent interpersonal skills
- Basic knowledge or understanding of FDA Quality System