Staff Systems Engineer Lead - Digital (Hybrid)
- Job Type:
- IT leadership
- $150k - $170k
- Ref #:
**New Permanent Role Staff Systems Engineer Lead - Digital (Hybrid)**
Location – USA NJ - Franklin Lakes
Salary $150k - $170k & Benefits Package
Industry – Medical Device
The Staff Systems Engineer is a Systems Lead position that is part of a team that designs, develops, builds, and commercialises complex digitally connected hospital systems focused on patient safety and clinical workflow. Specifically, this position will be responsible for system definition (user needs, system requirements, system architecture, and supporting decomposition to subsystem requirements, particularly software epics and user stories), risk analysis, verification, validation, and system traceability. This role will have particular focus on usability integration with the system design and development to include supporting various user studies as well as testing and validation and incorporating usability and user risk into system definition, design, and test. This role will also be serving as a lead role to build a digital systems capability within the systems team, and to provide mentorship in the areas of systems engineering methodologies, systems integration, and systems thinking, particularly in combined digital and hardware system development projects.
The Staff Systems Engineer role includes the following responsibilities:
- With minimal supervision, lead systems design, definition, integration, and test planning, provide advanced systems engineering skills, technology development, and product evaluation support, particularly in a digitally connected environment
- Provide leadership to a growing systems and test team
- Lead multi-functional teams to develop system design inputs, interface requirements where appropriate, and facilitate system risk assessment across different technologies and business units, Lead design inputs and drive decomposition and trace to sub-systems
- Actively develop the systems capability and in particular a digital systems capability in the team, and provide mentorship and learning opportunities for the systems, R&D, and project teams
- Lead multi-functional teams to develop use cases and use risk analysis and ensure incorporation into system definition (requirements and risk analysis) and design
- Create solutions for technical problems using systematic problem-solving methodologies.
- Lead and support periodic design reviews of projects.
- Maintain and develop an ongoing overview of relevant emerging technologies and products and conduct hands-on evaluation of competitive products, materials, and procedures.
- Develop an understanding of internal and external customer needs and processes to ensure relevant and innovative solutions
- Drive external subsystem (software and hardware consumable) development activities.
- Ensure compliance with internal quality policies and procedures, as well as applicable laws and standards.
- BS in Systems Engineering, Biomedical Engineering, Software Engineering, or equivalent.
- Masters or PhD is preferred.
- A minimum of 8 years’ experience with the development of complex digitally connected systems
- Proficiency in development of user needs and product requirements, interface requirements, risk assessments, test plans, protocols, and reports
- Exposure to human factors engineering (preferably in the medical space) including user studies and usability documentation
- Experience in digital systems, and digitally-connected electromechanical sensing systems
- Experience as member of a multi-functional project team
- Expertise in common risk management techniques (SHA, FMEA, FTA, ETA)
- Working knowledge of international standards applicable to medical devices, including ISO13485, ISO14971, IEC 62304, IEC62366, and IEC60601 and its collateral standards
- Experience in a hybrid digital-hardware medical device systems that integrate phase-gate and Agile processes
- Experience in Phase-Gated Product Development process
- Medical device product development or other regulated product development experience
- Experience with hospital EMR-connected systems
- Experience in Agile concepts and processes
- Excellent interpersonal, articulate communication, presentation and influencing skills
- An ideal candidate for this position will have a profound attention to detail, systematic problem solving skills, a strong desire to learn and acquire new skills and knowledge with a strong bias for action.
- Provide engineering skills, technology development, and product evaluation support
- Leadership and mentoring skills
- Implement, monitor and deliver designated tasks and deliverables. Be accountable for success of assigned tasks and deliverables as well as team tasks and deliverables.
- Resolve complex technical problems. Create solutions for technical problems using systematic problem-solving methodologies.
- Ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures
- Must be comfortable making practical assumptions with engineering justifications, where needed.
- Ability to work independently.
- Ability to work under pressure and time constraints.
- Strong organizational skills.