Plan, execute, and complete Quality Engineering deliverables on schedule, including manual and automated test plans, test procedures, scripts, and reports. Lead and coordinate test planning and execution activities, ensuring alignment with project schedules and cross-functional dependencies. Acquire and apply a strong understanding of testing methodologies, processes, tools, templates, and test environments to effectively support assigned projects. Clearly communicate and support team members and cross-functional partners in understanding testing strategies, processes, tools, and quality concepts. Develop, review, and maintain standard operating procedures (SOPs), specifications, and test procedures in accordance with Quality System requirements. Execute Design Verification and Validation (V&V) activities, including hands-on testing, test automation development as appropriate, and cross-functional root-cause analysis and issue resolution. Participate in and provide quality input during system, software, and firmware requirements reviews, design reviews, and code inspections, leveraging static analysis and test-driven development (TDD) practices as applicable. Review and assess test protocols, procedures, and test results generated by other functional groups to ensure accuracy, completeness, and complianceSupport product Risk Management activities, including identification, assessment, and verification of software-related risk controls. Proactively identify opportunities to improve software and firmware design reviews through enhanced quality tools, checklists, and review practices. Drive continuous improvement of the software and firmware testing lifecycle through the introduction and adoption of effective tools, automation, and best practices. Ensure Design History File (DHF) content is complete, accurate, traceable, and compliant with applicable regulatory and standards requirements, and collaborate to resolve gaps. Support internal and external audits, inspections, and associated responses, including preparation and resolution of observations. Support the definition and verification of objective, measurable, and verifiable customer and product requirements. Review and approve Document Change Requests in a timely, thorough, and objective manner. Additional duties may be identified by functional management based on the current project/business objectives. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. 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. QUALIFICATIONS - Education. Bachelors Degree (± 16 years) in an Engineering or Technical Field (OR) an equivalent combination of education and work experience. Experience/ Background. Minimum 2 years 2–5 years of combined experience in software development and/or embedded systems applications .–5 years of combined experience in software testing and verification/validation. Programming experience in one or more of the following languages or environments: C, C , C#, Python, Java, Visual Studio, etc. Experience using software configuration management and defect tracking tools such as Git, Jira, Subversion, Clear. Quest, DOORS, Bugzilla, or equivalent. Experience with code review and static analysis tools (e.g., Code Collaborator, Coverity, Parasoft DTP) to support software and firmware quality assessments. Experience working as a team member in Agile or iterative software development lifecycle (SDLC) programs. Working knowledge of multiple software and test lifecycles, including V-Model, Iterative, and Agile/ Scrum methodologies. Experience supporting automated test execution and coordination. Ability to work effectively in a highly matrixed and geographically diverse environment. Ability to contribute both as an individual contributor and as an effective team member in a fast-paced, changing environment. Demonstrated ability to influence and collaborate with cross-functional partners to accomplish project objectives. Strong verbal and written communication skills, with the ability to communicate effectively at multiple levels within the organization. Proven ability to prioritize, multitask, and meet deadlines in a dynamic work environment. Strong organizational, follow-up, and attention-to-detail skills. Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to leverage and/or engage others to accomplish projects. Apply Now. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: