Systems Engineer

Education:
Bachelor's degree in Electrical, Mechanical, Software, Biomedical Engineering or related field
Required Qualifications:
3+ years of relevant experience
A demonstrated track record in system development covering requirements management, risk management, cybersecurity, usability, performance and reliability
Experience in using tools/practices like QFD, Pugh Matrix, CTQ, DFR, DFX
Excellent communication, inter-personal and leadership skills
Firm decision maker and shall possess good influencing skills
Openness to collaborate in interest of project/organization
Must have strong organizational skills
Works independently, is self-motivated and able to complete tasks with minimal supervision
Must have the ability to initiate and develop creative solutions
Acts with a sense of urgency, illustrates ambition and drives for completion of tasks/projects
Strong proficiency in Office applications skills
Must be a team player, possess outstanding customer service skills and be self-motivated
Possess good listening skills, and easily learn new skills and concepts
Ability to manage time and prioritize work
Must be flexible and adaptable

Preferred Qualifications:
Systems development experience in diagnostic cardiology medical devices or any other medical device is a definite plus
Agile product development experience preferred

System Engineer Summary:
Responsible for coordination and management of system design for one or more groups of related products (i.e. Programs) to achieve defined program goals
This includes work related to the maintenance and engineering support of existing products
Interfaces with other departments including Marketing, Sales, Service, Operations, Quality Assurance and Regulatory Affairs to define product requirements, communicate important information, and address issues relative to each product

Job Duties:
Accountable for the entire product development process - from engaging with customers and marketing to compose and develop user needs, to the eventual product launch
Work with Engineering Project Management to define and scope projects to achieve program goals
Participate as a member of project teams for the assigned program
Work with Upstream Marketing to understand and translate market needs into technical product requirements
As a leader of the technical team, ensure technical product requirements are communicated and understood by the development team
Owner of the Design History File (DHF)
Responsible for ensuring technical product requirements are clearly and thoroughly documented
Creation of system level specifications
Ensures usability requirements are adequately addressed per IEC 62366
Lead technical resource for Risk Management per IEC 14971
Coordination and review of design level requirements to ensure they meet the system requirements and market needs
Coordination and review of system and design level requirements to ensure they adequately consider serviceability and manufacturability of the product
Responsible for DHF traceability by ensuring all requirements have been verified and validated
This includes creation of Verification and Validation Plans to scope the extent of testing required to maintain adequate traceability is maintained during a development project
This also includes completion of all documentation required to ensure compliance to standards
Ensures requirements shared by similar products and their implementations are harmonized across those products, where possible
Work with technical writing to ensure user documentation is sufficient
Plays a critical role in product development, making sure the product meets all the functional and performance requirements, and ensuring the manufacturing and service requirements are translated into product design
Lead the development and documentation of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications
Provide technical leadership to the development team to ensure that the project successfully meets cost, quality, and schedule targets throughout the product life cycle
Resolve competing constraints between interrelated functions (engineering, manufacturing, regulatory, marketing, etc.) required to deliver the product to market
Plan and carry out system integration tasks to reduce problems in systems verification and validation
Document traceability from requirements to verification activities, and from requirements to design entities
Resolve systems-related technical issues by applying problem solving tools such as cause and effect diagrams, Pareto charts, etc
As lead integrator for the product, proactively look out for integration issues during development tests and ensure module/system development is successful
Adheres to Quality Management system & supports the quality audits
Ensure end product configurations (MIS-14s, etc.) are created and updated as necessary to meet the market needs