MAIN PURPOSE OF ROLE:
The Director of Systems Engineering MCS has direct accountability for driving the technical direction of the Systems Engineering group with the Mechanical Circulatory Support R&D group. Responsible for managing the capabilities of the group to ensure business objectives are met as it pertains to systems engineering, new technology and product development. This individual and their team will integrate closely with multi-disciplinary engineering team members and cross-functional teammates to help define and develop new products.
MAIN RESPONSIBILITIES: Accountable and responsible for leading the Systems Engineering team to develop systems, including defining needs, requirements, architecting solutions, testing and validating designs to meet customer needs and objectives.Provides technical guidance and oversight to support the integration and verification of subsystems.Leads a team of engineers that manages and oversees the design, integration, test, verification, and validation of mechanical circulatory support devices and accessories.Serves as a lead technical reviewer to ensure application of robust engineering practices and methods in design and development activities.Mentors and coaches engineering staff as necessary to ensure engineering, data analysis, and scientific principles are applied appropriately.Drives continuous improvement of systems engineering processes in the team and strives to implement the highest standards of quality into product development activities.Collaborates across other groups, businesses and external partners to identify and implement best practices and benchmarks.Collaborates with leadership and peers from other departments of a cross-functional organization to ensure business goals and objectives are met.Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.Maintains a safe and professional work environment.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.QUALIFICATIONS: Education Bachelors Degree (± 16 years) in Computer Science, Statistics, Engineering, Physics, or a related field.Progressively increasing experience in application of systems engineering tools and practices and its application in product development. Strong track record of technical leadership through implementation of engineering tools and practices a must.Minimum 4 years
Supervisory/managerial experience.Demonstrated understanding and familiarity with applicable FDA regulations and international standards preferred.Experience working in a broader enterprise/cross division business unit model preferred.Ability to work in a highly matrixed and geographically diverse business environment.Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.Ability to work effectively within a team in a fast-paced changing environment.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multi-tasks, prioritizes and meets deadlines in timely manner.Strong organizational, planning, and follow-up skills and ability to hold others accountable.Ability to travel, including internationally.
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