Overview The Software Engineer, Medical Device team is responsible for designing, developing, and supporting software solutions that meet regulatory and quality requirements throughout the entire product lifecycle. Responsibilities Develop and apply engineering methods and tools to support the software development lifecycle, from requirement gathering to final implementation, testing, and documentation. Conduct research and incorporate advanced technologies and engineering concepts relevant to the medical device industry. Ensure internal and external customer expectations are met or exceeded while working independently, with occasional guidance from supervisors or mentors. Apply the company’s Quality Management System (QMS), FDA regulations, safety, environmental, and security requirements to all work. Evaluate, select, and apply standard engineering techniques, and adapt specifications to fit project needs while maintaining quality and compliance. Review and assess procedures, plans, and existing products or processes for failure analysis, improvement opportunities, and root‑cause determination. Participate in projects that involve the development, documentation, and implementation of moderate‑complexity product and process technologies. Demonstrate proactive insight, mitigate potential issues, and incorporate improvements throughout the project lifecycle. Plan, schedule, and execute engineering work within larger project scopes, or lead smaller‑scope projects as required. Apply data‑analysis practices to establish root causes for product and process failures, supporting justification for improvement actions. Collaborate with cross‑functional teams, exchange information, ask clarifying questions, and confirm understanding to support personal and team development. Champion a culture of continuous improvement and quality ownership across all engineering activities. Performance Metrics Safety: Actively support the Environmental Health & Safety program. Quality: Achieve and exceed site Quality Key Performance Indicators and KPIs related to product and process improvements. Innovation: Generate and implement continuous‑improvement suggestions. Efficiency: Identify opportunities to shorten project durations and improve processes and procedures. Qualifications Bachelor’s degree in Computer Software Engineering or a related technical field (minimum three years of relevant experience). Candidates with 7+ years of experience may be considered if they do not meet the education requirement. Strong proficiency in mobile application development using Swift and Kotlin Multiplatform. Familiarity with Agile development methodologies and Object‑Oriented Design principles. Strong analytical thinking, problem‑solving skills, and clear technical communication. Experience with Microsoft .NET C# desktop development is a plus. Knowledge of IEC62304 or other regulated development processes is highly valued. Ability to work independently while also collaborating effectively with cross‑functional teams. Functional understanding of the company’s Quality Management Systems and the ability to complete required quality documentation with minimal direction. Proficiency in writing and speaking Spanish and English. Maintains a calm, can‑do attitude in a high‑energy, constantly changing environment. Equal Opportunity Statement Integer is an equal‑opportunity employer. The company does not discriminate based on race, color, sex, religion, national origin, or any other protected characteristic. Veterans and individuals with disabilities are encouraged to apply. Integer provides reasonable accommodations for qualified applicants who need them. #J-18808-Ljbffr