Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
At Thermo Fisher Scientific, we believe in taking on challenging initiatives as part of a team that prioritizes high achievement, quality, and innovative ideas. As a member of a thriving and rapidly growing global corporation, you will be empowered to succeed With a $20 billion revenue and the industry's largest R&D investment, we offer our employees resources and chances to lead meaningful transformation.
Position Summary:
The Systems Engineer III is tasked with spearheading the conception, formulation, and deployment of advanced medical device systems. This role involves collaborating closely with diverse teams to ensure products align with customer needs and regulatory standards. The Systems Engineer III will lead all aspects of intricate projects, mentor less experienced engineers, and manage system engineering tasks.
Responsibilities:
* 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 (e.g., FDA, ISO
* 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.