Job Description

MAIN PURPOSE OF THE ROLE

The Senior Systems Engineer is responsible for understanding interdisciplinary, collaborative approach to plan, design, develop the integrated set of standards, sub-standards, and assemblies needed to design and manage systems over their life cycles. Applies an interdisciplinary, collaborative approach to plan, design, develop and verify a life-cycle balanced system of systems and system/subsystems solution(s) which satisfies customer/operational needs and public/regulatory acceptability. This includes a multitude of systems requirements that range from design, development, test methodologies, validations, risk analysis, documentation, and process improvements. This includes owning systems requirements, system design, development, test methodologies, risk analysis, documentation, and process improvements supporting the remote monitoring and digital health product portfolio.

MAIN RESPONSIBILITIES

• 1. Creates & defines system requirements, system specifications and input/output process, etc. Analyzes system requirements, user needs, system design, and coordinates system evaluation activities.

• 2. Leads technical discussion for system level design reviews, development and testing to assess performance against design specification; reliability testing, and assessment of system interactions.

• 3. Provides system level technical support in developing manufacturing system software processes and troubleshooting issues to determine root cause and potential engineering solutions. Proactively monitors the system level health of the product and identifies potential issues. Technical systems lead in documenting system requirements by writing documents, reports, memos, change requests, etc. Methods used are determined by approved procedures and standards.

• 4. Conducts and/or provides guidance on special studies or experiments to improve systems engineering practices, system quality, and define new components, products or processes. Independently designs and executes experiments. Utilizes DOE (Design of Experiments) as appropriate.

• 5. Leads moderately complex issues to determine root cause. Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving System level issues. Utilizes DMAIC and/or other investigation tools as appropriate. Teaches and mentors systematic problem-solving methodologies to other members within technical community

• 6. Applies process efficiency tools to improve proficiently within process and work methodologies. Collaborates with various engineering disciplines and other cross-functional groups to optimize system solutions.

• 7. Ensure relevant engineering knowledge and skills are up-to-date (e.g. methods and tools within software engineering, mathematics, requirements engineering, risk management, good documentation practices, product development, etc.) Clear understanding of Medical Device Regulations and quality sub-systems including Risk Management, CAPA, and Design Planning. Applies engineering/ process knowledge to support system engineering activities.

• 8. Leads collaboration with various technical disciplines (e.g., design, test, software, technology) through knowledge of the interaction between departments/disciplines and how their products/processes affect one another and impact non-engineering processes (e.g. Operations, Logistics, Business, Quality). Monitors performance of cross-functional teams against complex timelines; develops contingency plans as needed; recommends across-site resource and strategy adjustments.

QUALIFICATIONS

Education

Education Level

Major/Field of Study

or

Equivalent

Bachelors Degree (± 16 years)

in Science, Technology, Engineering and Mathematics (STEM)

Experience/Background

Experience

Experience Details

Minimum 6 years

of relevant experience in systems engineering

i. Demonstrated experience leading complex system and risk analysis.

ii. Demonstrated ability to lead and utilize data to make decisions and influence stakeholders.

iii. Demonstrated success in technical proficiency, creativity, and independent thought. Experience with system level concept creation, evaluation and innovation

iv. Experience with system analysis, model-based system engineering and system architecture

v. Excellent verbal and written communication skills.

vi. Proven Knowledge of System Engineering principles or concepts.

vii. Demonstrated ability to apply principles of systems thinking to accelerate performance.