Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation.
Impacts departmental operations and responsible for planning/execution. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures. Some judgment may be required but this is typically with guidance.
Roles and Responsibilities
- Responsible for the theory, design, development and practical implementation of product safety engineering methodologies and techniques for equipment and devices. Execute a process to identify and mitigate safety risks inherent to the product design to an acceptable level; conduct rigorous safety risk assessments, hazard evaluations, utilize human factors principles to drive design improvements in order to eliminate human error in the operation and maintenance of the product in the field
- Developing in-depth knowledge of a technical discipline. Uses prior experience and acquired technical expertise to execute policy/strategy.
- In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
- Uses some level of judgment and has ability to propose different solutions outside of set parameters but with guidance. Uses prior experience and on-the-job training to solve straightforward tasks. Has access to technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
- A job at this level is likely to be an individual contributor with proven interpersonal skills or an early people leader who can hire and develop talent. Provides informal guidance to new team members
Required Qualifications
- Bachelor’s degree in safety, Electrical Engineering, Biomedical Engineering or closely related discipline
- 5 years relevant work experience
- Ability to prioritize, plan & evaluate deliverables
- Knowledge & experience conducting design, regulatory.
Desired Characteristics
- Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
- Master’s degree in safety, Electrical Engineering or Biomedical Engineering
- Strong working knowledge of Medical Device regulations, NMPA/FDA/MDR/MHLW
- Experience with IEC 60601-1 serial standard.
- Excellent interpersonal, organizational, communication and influencing skills
- Demonstrated problem solving ability and results orientation
- Knowledge of Quality Management Systems (QMS).
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.