<p>Job Title</p> <p>Senior Systems Engineer</p> <p>Requisition</p> <p>JR000015742 Senior Systems Engineer (Open)</p> <p>Location</p> <p>College Park, Dublin - IRL006</p> <p>Additional Locations</p> <p>Job Description Summary</p> <p>Job Scope</p> <p>Systems Engineering is an engineering discipline focused on creating and executing an interdisciplinary process to ensure that the customer and stakeholder's needs are satisfied in a high quality, trustworthy, cost-efficient and schedule-compliant manner throughout a system's entire life cycle.</p> <p>The Senior Systems Engineer will lead system definition / development activities in one or more medical device development projects, and act as a contributor to other projects.</p> <p>Job Description</p> <p>Roles and Responsibilities</p> <ul> <li>Understands the intent, constraints and value proposition of a given project. Aligns system engineering activities to meet these. </li><li>Acquires expertise in existing device performance and behaviour to guide lifecycle management projects. </li><li>Translates User Needs (from multiple internal and external stakeholders) into verifiable technical design requirements. </li><li>Creates and assesses system architecture options with cross-functional (electrical / mechanical / SW) team to define optimal system solutions. </li><li>Decompose system requirements to subsystem requirements (including SW), ensuring functional coverage. </li><li>Assesses technical challenges using a systems engineering mindset. Uses recognised problem-solving techniques to arrive at data-driven solutions. </li><li>Executes work under Keenova's design controls process and in compliance with the company's quality management system. Proactively improves product quality through their project work. </li><li>Works with program managers to help create project schedules. Leads and facilitates architectural and design decisions to ensure on-time delivery of projects. Escalates technical issues in a timely fashion to Systems Engineering leadership. </li><li>Works with multiple internal stakeholder groups (Verification, Validation, Quality, Commercial, Clinical, Regulatory Affairs etc.) to resolve system definition challenges. </li><li>Assesses and clearly communicates technical status of projects. </li></ul> <p>Experience, Qualifications and Education Requirements</p> <ul> <li>BS or MS degree in a scientific or engineering discipline. </li><li>5+ years Systems Engineering experience in complex electro-mechanical products. </li><li>2+ years medical device development experience. </li><li>Applied knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, IEC 60601, IEC 62304 etc.). </li><li>Familiarity with requirements management tools (e.g., Jama Connect) and diverse data management tools is preferable. </li></ul> <p>Competencies / Preferred Skills</p> <ul> <li>Facilitation and presentation skills: Strong ability to engage and influence diverse audiences. </li><li>Communication and interpersonal skills: Excellent verbal and written communication, with proven ability to collaborate effectively across cross-functional teams. </li><li>Organisation and time management: Strong ability to manage multiple priorities and deadlines in a dynamic environment. </li><li>Attention to detail and compliance focus: High level of accuracy with a strong emphasis on GDP compliance and documentation standards. </li><li>Operational agility: Comfortable operating in fast-paced, project-driven environments. </li><li>Problem-solving and continuous improvement: Demonstrated capability to identify issues and drive process optimization and operational improvements. </li><li>Adaptability and initiative: Proactive and self-directed, with the ability to anticipate challenges and drive effective solutions independently. Takes ownership of their tasks. </li><li>Collaboration and knowledge sharing: Strong team-oriented approach. Gains consensus, leads, influences and ensures cross-discipline participation and feedback. </li></ul> <p>At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.</p> <p>We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.</p> <p>We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.</p>