Staff Systems Engineer (Hybrid)

**New Permanent Role Staff Systems Engineer (Hybrid)**

Location – USA NJ - Franklin Lakes
Salary $150k & Benefits Package
Industry – Medical Device

The Staff Systems Engineer is part of a team that designs, develops, builds, and commercializes complex digitally connected electromechanical sensing systems focused on patient safety and clinical workflow. Specifically, this position will be responsible for system definition (user needs, system requirements, system architecture, and decomposition to subsystem requirements), risk analysis, verification, validation, and system traceability. This role will have some focus on usability to include supporting various user studies as well as testing and validation and incorporating usability and user risk into system definition, design, and test. Responsibilities for the Systems Engineer include defining, clarifying, and documenting requirements; performing the necessary parametric analysis and trade-offs; recognizing when interface impacts might occur and taking early action to avoid problems. The candidate is expected to utilize quantitative approaches to design activities, system, and technology integration, and have strong capabilities and experience in systems engineering and processes, and diversified interdisciplinary experience and knowledge. This position will be part of a cross-functional team that collaborates with external partners, develops, and manages requirements, generates system and component concepts, implements the solutions in hardware and software, performs experiments, analyses data, and ensures robust verification and validation testing. and have strong capabilities and experience in systems engineering and processes, and diversified interdisciplinary experience and knowledge.

JOB DESCRIPTION:

The Staff Systems Engineer role includes the following responsibilities:

RESPONSIBILITIES:

• With minimal supervision, lead systems design, definition, integration, and testing effort, provide advanced engineering skills, technology development, and product evaluation support.
• Potential to lead and delegate effectively to 3-6 systems and test team
• Lead multi-functional teams to develop use cases and use risk analysis and ensure incorporation into system definition (requirements and risk analysis) and design
• Plan, implement, monitor, and deliver designated tasks and deliverables. Be accountable for success of assigned tasks and deliverables as well as tasks and deliverable of R&D team members
• Design, assemble and evaluate rapid prototype models to assess technical feasibility of various solutions.
• Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements.
• Create solutions for technical problems using systematic problem-solving methodologies.
• Participate in periodic design reviews of projects.
• Maintain an overview of relevant technologies and products and conduct hands-on evaluation of competitive products, materials, and procedures.
• Author protocols and reports including engineering studies using basic statistical methods.
• Develop an understanding of internal and external customer needs and processes to ensure relevant and innovative solutions.
• Actively participate in training to improve skills. Ensure technical lessons are reviewed, learned, and disseminated. Actively teach and promote learning. Formal and informal written and verbal communication within the team and with the rest of the organization to ensure dissemination of important information.
• Drive external subsystem development activities.
• Ensure compliance with internal quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.
• Ensure compliance to applicable laws and standards.

QUALIFICATIONS:

Education:

• BS in Mechanical Engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering, Applied Physics, Software Engineering, or equivalent. 
• Masters or PhD is preferred.

Experience:

• A minimum of 8 years' experience with the development of complex system
• 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
• Development and execution of system verification and validation activities
• Experience in requirements management and traceability
• Experience in digital systems, and digitally connected electromechanical sensing systems
• Experience as member of a cross 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, IEC62366, and IEC60601 and its collateral standards.

Assets:

• Experience in the development of complex instrument systems involving hardware, electronics, and optics, ideally in a healthcare, medical technology or life sciences area
• Experience in Phase-Gated Product Development process
• Experience contracting with, and managing, third party hardware consultants within and outside the US
• Experience with hospital EMR-connected systems
• Experience in Agile concepts and processes

Additional Skills:

• Excellent interpersonal, articulate communication, presentation and influencing skills
• Quick learner
• 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. 
• With supervision from project leaders, provide engineering skills, technology development, and product evaluation support.
• Implement, monitor and deliver designated tasks and deliverables. Be accountable for success of assigned tasks and deliverables.
• Resolve technical problems. Create solutions for technical problems using systematic problem-solving methodologies.
• Participate in periodic design reviews of projects.
• Design, assemble and evaluate rapid prototype models in order to assess technical feasibility of various solutions.
• Ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures
• Ensure compliance with internal quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. Conduct hands-on evaluation of competitive products, materials, and procedures.
• Strong sense of accountability and action orientation
• Design for six sigma
• Systematic problem-solving skills, a strong desire & ability to learn and acquire new skills, knowledge, and subject matter.
• Ability to identify, break down and solve complex technical problems.
• 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.
• Effective interpersonal and collaborative skills.
• Effective meeting and presentation skills.