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Lead Engineer, Health Systems Test

Job Description

The Lead Engineer, Health Systems Test, will define the overarching system test strategy (HW/SW), appropriate system level tests (test protocols, test methods, documentation), and aid in the quality delivery of system features for a medical wearable technology. This role will interact with customers/partners and their verification and validation testing teams, and will work closely with health developers and engineers to verify and validate the design of a platform that will be used in the hospital operating room, clinic, and home setting. The candidate will also work in collaboration with other engineering disciplines, regulatory, quality, systems design, product management, program management, and partners to deliver products according to the product development roadmap. The candidate will need systems engineering principles in requirements testing, system testing, design of experiments, regression testing, exploratory testing, issues management, and modifying designs using agile methodologies.

Responsibilities:

• Accountable owner for system verification and validation testing, ensuring that health platform requirements and acceptance criteria are satisfied. Work to oversee, create, execute, and document verification activities for software and hardware components.
• Generate system level verification and validation testing strategy and system test planning, aligning with Project Managers and project deliverables, to set and meet important project deadlines.
• Collaborate with the quality assurance team on continuously defining, maintaining, and optimizing internal procedures for verification and validation at the system, subsystem, and component level as well as procedures for defect management, software risk analysis, and release management.
• Work closely in conjunction with internal human factors, systems, mechanical, electrical and software engineers, when discovering, documenting, and resolving issues.
• Lead efforts related to performance compliance to requirements and root cause investigations to determine source of inefficiencies in design and collaborate on finding resolution.
• Create, execute and validate test methods with Gage R&R studies and execute system level test protocols including statistical analysis on data collected for verification of health platform requirements.
• Set, maintain, and work on existing and new internal tools and processes for system verification and validation test management, issue/defect management, and field complaint management.
• Guide colleagues on techniques and industry quality standards for system verification and validation best practices.

Qualifications:

• 7+ years experience working hands-on in system level hardware and software verification and validation testing for a medical device or SaMD in a medical regulated environment (FDA/EU). Lower experience candidates with similar qualifications will be considered as appropriate.
• Excellent written, verbal and presentation communication skills to present to various levels of leadership within the organization and prior demonstrated leadership testing strategy and planning.
• Strong understanding of design of experiments, and data analysis methods as per other industry standards.
• Experience in generating system test methods/cases/protocols for requirements verification/validation, and proper recording of results using good documentation practices.
• Experience with JMP, Minitab, Matlab or other software for statistical analysis. (ANOVA, t-test, tolerance interval, normality test, etc.)
• Experience in testing Graphical User Interfaces, Algorithms, 3D/2D model visualizations, and expected system behavior and performance.
• Experience in creating test benches and use of common testing tools (Instron, Force Gauges, FARO, etc…) is strongly preferred.
• Knowledge of C, C++, and/or Python is strongly preferred.
• Knowledge of Jira, Rally, or other task and issue tracking software is strongly preferred.
• Knowledge of git, svn, gerrit, and/or testrail is strongly preferred.
• Knowledge of cloud based technologies and load testing is preferred. (PaaS, SaaS, Storage)

• BS in Mechanical/Biomedical/Electrical Engineering or another related field; MS preferred

Additional Information