Senior Systems Engineer
Mallinckrodt Pharmaceuticals View all jobs
- Dublin
- Permanent
- Full-time
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.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.Job DescriptionRoles and Responsibilities
- Understands the intent, constraints and value proposition of a given project. Aligns system engineering activities to meet these.
- Acquires expertise in existing device performance and behaviour to guide lifecycle management projects.
- Translates User Needs (from multiple internal and external stakeholders) into verifiable technical design requirements.
- Creates and assesses system architecture options with cross-functional (electrical / mechanical / SW) team to define optimal system solutions.
- Decompose system requirements to subsystem requirements (including SW), ensuring functional coverage.
- Assesses technical challenges using a systems engineering mindset. Uses recognised problem-solving techniques to arrive at data-driven solutions.
- 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.
- 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.
- Works with multiple internal stakeholder groups (Verification, Validation, Quality, Commercial, Clinical, Regulatory Affairs etc.) to resolve system definition challenges.
- Assesses and clearly communicates technical status of projects.
- BS or MS degree in a scientific or engineering discipline.
- 5+ years Systems Engineering experience in complex electro-mechanical products.
- 2+ years medical device development experience.
- 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.).
- Familiarity with requirements management tools (e.g., Jama Connect) and diverse data management tools is preferable.
- Facilitation and presentation skills: Strong ability to engage and influence diverse audiences.
- Communication and interpersonal skills: Excellent verbal and written communication, with proven ability to collaborate effectively across cross-functional teams.
- Organisation and time management: Strong ability to manage multiple priorities and deadlines in a dynamic environment.
- Attention to detail and compliance focus: High level of accuracy with a strong emphasis on GDP compliance and documentation standards.
- Operational agility: Comfortable operating in fast-paced, project-driven environments.
- Problem-solving and continuous improvement: Demonstrated capability to identify issues and drive process optimization and operational improvements.
- Adaptability and initiative: Proactive and self-directed, with the ability to anticipate challenges and drive effective solutions independently. Takes ownership of their tasks.
- Collaboration and knowledge sharing: Strong team-oriented approach. Gains consensus, leads, influences and ensures cross-discipline participation and feedback.