Job Description

　　THE ROLE

　　Lead the system development of complex clinical diagnostic devices using state-of-the-art system engineering practices. This highly interactive role will work with cross-function teams and support various development activities including requirement creation, system conceptualization, risk assessment, system verification and validation.

　　Lead the integration of software, electro-mechanical hardware and assays.

　　Build and maintain subject matter expert status by working “hands on” with the products regularly in the lab.

　　Implement and utilize system engineering tools for requirements management and translate user and business needs into system/sub-system requirements.

　　Participate in system design/review meetings to ensure appropriate integration and connectivity within overall system.

　　Interface with key external development partners

　　Define and maintain design history files, the traceability from the requirements to the verification activities and related deliverables.

　　Identify and execute on opportunities for process improvement in a fast paced and growing organization.

　　Maintain up-to-date knowledge of medical devices, technologies and regulatory landscape relate to the company’s products.

　　Support field investigations to ensure customer satisfaction.

　　IDEAL CANDIDATE / REQUIREMENTS

　　Bachelor or more advanced degrees in Systems Engineering, Electrical/Electronic Engineering, Computer Science, Biomedical Engineering or other relevant disciplines

　　Experience covering medical device product development from concept to commercial launch, working with the requirements and traceability management tools

　　Experience managing the technical work of external development partners

　　Strong analytical skills and ability to apply engineering principles using logical or scientific thinking to define and solve problems, collect data, establish facts, and draw valid conclusions

　　Ability to cope with complexity of inter-disciplinary development team coordination

　　Experience managing the technical work of external development partners

　　Ability to multi-task, stay organized, and independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines

　　Ability to capture and decompose customer needs into device and sub-systems requirements and engineering specifications. Document design input & output.

　　Provide solid technical skill and engineering support for design, development, and troubleshooting activities

　　Strong motivation to drive challenging projects to completion balancing multiple competing priorities in a dynamic environment

　　Strong interpersonal and communication skills and ability to effectively work in a diverse, team driven environment

　　Strong English written and verbal communication skills with both technical and non‑technical users.

　　Experience with the following a plus:

　　Privacy and Security

　　Human Factors Engineering

　　Product Compliance Engineering

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.