Job Description Summary # Job Description The statements below are intended to describe the general nature and level of work being performed by associates assigned to this job. This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of associates so classified. Systems Engineers are responsible for technology integration in smart instrumented solutions to patient safety within the healthcare environment with multiple subsystems and components. These individuals are members of a team that ensures adequate system level performance for instrumented medical devices through close collaboration with peers in mechanical and electrical engineering design, software development and other functional groups. They have a broad knowledge base that includes electromechanical instrumentation and application in the medical field and apply this knowledge to address issues from technology development to product development to product commercialization and launch. System Engineers are characterized by their disciplined, quantitative approach to system and technology integration as well as diverse cross-functional backgrounds and experiences. These individuals deploy tools and processes such as Design for Six Sigma, apply quantitative approaches to design activities and take responsibility for effective qualification of the product to enable more predictable product development with high quality/value products. In addition to technical expertise, system integrators bring strong leadership and team building skills. The Systems Engineer role will be responsible for determining and ensuring comprehensive system integration of electromechanical devices. This includes defining, clarifying, and documenting requirements; performing the necessary parametric analysis and tradeoffs; recognizing when interface impacts might occur and taking early action to avoid problems. This position is expected to utilize quantitative approaches to design activities, to system and technology integration, 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, analyzes data, and ensures robust verification and validation testing. RESPONSIBILITIES: + Responsible for identification and management of user and product requirements and high-level design specifications including integration plans for modules and components into complete system + Contributes to product conceptualization and develops work plans to reduce concept to design + Assumes a technical contributor role and works closely with other functional groups including hardware/software engineering. + Independently evaluates problems of significant complexity and applies analytical/scientific principles to fulfill project and business objectives + Implements DFSS and technology excellence practices and conducts and contributes to periodic design reviews of the system + Ensures compliance with internal quality procedures and practices and external applicable laws and standards. + Works closely with external partners to drive subsystem development activities. + Devises system assessment strategy and works closely with test team to create robust test methods and apply conclusions to design and development activities. + Conceptualizes, develops and executes on reliability engineering methodology (such as HALT/HASS) and contributes to the transition from R&D to manufacturing and to system troubleshooting activities for products in the field. + Acts independently within team expectations, provides guidance and work assignments to less experienced team members, consults with functional leadership to identify associates to complete tasks under his/her accountability. + May train, develop or assign work to others; provides technical guidance to less experienced engineers. Ensure technical lessons and important information are reviewed, learned and disseminated. Minimum Qualifications: + B.S in Mechanical Engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering (EE concentration), Applied Physics, Software Engineering, or equivalent. + A minimum of 5 years’ experience with the development of complex electro-mechanical system Desired Qualifications: + Masters or PhD is preferred. + Ten or more years’ experience with the development of complex electro-mechanical system + Technical leadership experience in medical space + Development of product requirements + Experience in architecting instrumented systems + Development and execution of verification and validation activities + Experience in requirements management and traceability + Experience in computer and networked devices + Design for Six Sigma, Design for reliability + Exposure to Human factors engineering (preferably in the medical space) including user studies and usability documentation + Experience as member of a cross functional project team + Expertise in common risk management techniques (FMEA, FTA, ETA). + Proficiency in writing requirements, specifications, test protocols, and test reports + Working knowledge of international standards applicable to medical devices, including ISO13485, ISO14971, and IEC60601 and its collateral standards ASSETS: + Experience in the development of complex instrument systems involving hardware, electronics, and firware/software, 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 U.S. ADDITIONAL SKILLS: + Excellent interpersonal, 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. + 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. + 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 + 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. Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. BD and Covid-19: To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location, but is temporarily remote-based due to Covid-19. Any offer of employment is contingent upon the candidate reporting to work at the site if/when associates are requested to return to the workplace. #LI-PRO # Primary Work LocationUSA NJ - Franklin Lakes # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.