:Take on the task of gathering and assessing user and collaborator needs for medical device systems.Translate requirements into detailed system specifications and compose documents.Develop and pioneer innovations in medical device systems, while adhering to regulatory guidelines (, FDA, ISO 13485).Conduct and lead development reviews, providing input on system architecture, composition, and functionality.Develop and maintain comprehensive system-level documentation, including requirements specifications, composition documents, and interface control documents.Perform system-level testing and validation to ensure device performance and safety.Identify and resolve intricate technical issues concerning medical device systems.Participate in and lead risk management activities, including hazard analysis and failure mode effects analysis (FMEA).Provide technical support and training to manufacturing and service teams.Follow the latest industry trends, technologies, and regulatory changes.Project Leadership:
Lead and manage system engineering projects, ensuring timely delivery and alignment to specifications.Mentor and guide junior engineers, encouraging their professional growth.Report progress and issues to senior team members and management.Collaboration:
Collaborate with assay development, software engineers, hardware engineers, quality assurance, and regulatory affairs to ensure successful project outcomes.Work closely with other departments to ensure seamless integration and functionality of systems.Documentation:
Ensure traceability of verification activities to requirements and risk management documentation.Preserve comprehensive documentation of all system engineering actions and achievements.Minimum Requirements/Qualifications:
A Bachelor’s or equivalent experience in Engineering or Science (Biomedical, Electrical, Mechanical, Software, Physics or related field).Experience
5+ years of experience in systems engineering or a related field.Knowledge of regulatory standards and guidelines relevant to medical devices (Preferred).Knowledge, Skills, Abilities
Proficiency in system development, implementation, and maintenance.Ability to develop customer-focused concepts to meet technical requirements.Excellent analytical and problem-solving skills.Ability to diagnose complex software and hardware issues.Strong verbal and written communication skills, with the ability to convey technical information to non-technical collaborators.Proven track record to work effectively in a team environment and lead multi-functional projects.Ability to adapt to changing technologies and methodologies in a fast-paced environment.Physical Requirements / Work Environment
Mixture of office and laboratory work.Infrequent light lifting (<10kg).Potential infrequent travel (4-6 times per year).Thermo Fisher Scientific values the diverse stories of each of our 70,000 dedicated employees. Join our team and play a part in our critical mission to support a healthier, cleaner, and safer world.