Systems Engineer

• 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