Lead Engineer. Systems Test, V&V, Health

About the Employer

Lead Engineer, V&V Systems Test, Health

Plantation, USA

Job Description

The Lead Engineer, V&V Systems Test, Health, will design and develop system level test protocols, test methods, documentation, and aid in the quality delivery of system features for a medical wearable technology. This role works closely with 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 development, system testing, design of experiments, and modifying designs using agile methodologies.

Responsibilities

  • Provide leadership for verification and validation testing, ensuring that platform requirements and acceptance criteria are satisfied.
  • 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.
  • Collaborate on the creation, execution, documentation of software system verification and validation in conjunction with software testing lead and platform teams.
  • Work closely with the internal system and quality teams on process improvements.
  • 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.
  • Support regulatory and quality assurance teams with external testing certification to achieve compliance with regulatory requirements. (Eg. 60601-1)
  • 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. Includes preparation and execution of IQ,OQ, and PQ for test equipment.
  • Work with health product and systems design leads in understanding and processing the system architecture and the creation of health platform requirements with the appropriate testable acceptance and performance criteria.
  • Guide less experienced colleagues on techniques and industry quality standards for system verification and validation best practices.
  • Responsible for tests that cover system functionality, usability, hardware/accessory security, and system reliability.
  • 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.

Qualifications

  • 7+ years experience working hands-on in V&V testing for a medical device or SaMD in a medical regulated environment (FDA/EU).
  • Excellent written, verbal and presentation communication skills to present to various levels of leadership within the organization and prior demonstrated leadership in product V&V efforts.
  • Strong understanding of system V&V testing, clinical study, and data analysis methods as per other industry standards, including strong skills with design of experiments.
  • Experience in generating system test methods/protocols for requirements verification/validation, and proper recording of results using good documentation practices.
  • Experience with Solidworks, Creo or other parametric modeling software.
  • Experience with JMP, Minitab, Matlab or other software for statistical analysis. (ANOVA, t-test, tolerance interval, normality test, etc.)
  • 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.

Education

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