Collabera System Validation Engineer in Mounds View, Minnesota
System Validation Engineer
Location:Mounds View, MinnesotaUS
System Validation Engineer
Job Summary: Support product development efforts as a key member of program teams by leading system-level validation activities to ensure that client products perform as designed and conform to user needs and intended uses.
• Reviews and analyzes design input requirements from a testability standpoint.
• Performs technical planning and performance evaluation studies, conducts technology assessment activities, analyzes system integration issues.
• Evaluates prototypes formally and informally through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirements.
• Develops system validation plans and test protocols. Develops detailed test procedures for system level testing and sub-system verification. Conducts and documents those tests.
• Experience with Design Verification Test Method documentation and Test Method Validation
• Ability to apply statistical analysis as related to sample sizes to be used for design validation
• Support system integration and effectiveness analyses for total systems. Work closely with partners to ensure adequate coverage between system integration, system verification, and system validation efforts.
• Evaluates, recommends, learns, trains about new validation and test tracing tools.
• Identify, propose, and assist in the implementation of process improvement initiatives. Identify organization strengths and weaknesses related to system testing and help create strategy for improvement.
• Identifies and resolves issues, escalating as appropriate.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Lead and provide work direction to technicians executing test activities. Ensure the test team understands the testing to be performed and correctly executes these activities in a timely manner.
• Bachelor of Science in Biomedical Engineering, Electrical Engineering, a related engineering field, or equivalent, including relevant coursework and/or work experience in product development.
• Minimum of 6 years of relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience.
• Training and experience in verification and validation processes, methods, and tools.
• Demonstrated ability to apply an expert understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
• Experience managing and mentoring other engineers
• Medical device industry experience preferred.
• Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5%, including internationally.
• Ability to maintain regular and predictable attendance.
TMV, Validation,Design Verification Test Method, Test Method Validation