BD (Becton, Dickinson and Company) Sr. Systems Engineer, R&D in Andover, Massachusetts
Job Description SummaryThe Senior Engineer, Systems participates in the product development process for electromechanical medical devices. They must be able to define the product or system in a functional sense and understand how the system is broken down into smaller, more digestible subsystems. They work collaboratively with all engineering disciplines through the design and development stages to develop, review, evaluate and select design concepts. They may be involved in troubleshooting and root cause investigation of problems. They may also be involved in verification and validation of the finished design. They are a multi-disciplined engineer who is able to understand and communicate issues, and able to work with the other engineering disciplines to identify and realize effective and robust solutions.
This person must ensure compliance with BD ethics, quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles. They must also ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures.
Accountable for assigned R&D deliverables for the program.
Conducts and encourages frequent formal and informal communication within the R&D team to ensure full engagement and efficient operation.
Development and maintenance of requirements traceability through various levels
Contributes to data-driven decision making by designing experiments and collecting, analyzing, and presenting data results.
Contributes to development of design concepts and solutions to complex technical problems.
Troubleshoot products down to the component level to characterize failures and document results
Definition and execution of analysis and experimentation to identify root cause of failure
Definition and execution of DOEs to characterize system/subsystem performance
Involved in the evaluation of risk and trade-offs of alternative design concepts
Development of product risk file and documentation
Ensures compliance with BD quality policies, procedures, and practices.
Ensures compliance with all local, state, federal, and BD safety regulations, policies, and procedures.
EXPERIENCE & EDUCATION:
B.S. in a technical field such as Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Physics, or Software Engineering, or a closely related technical degree.
Minimum of 4 years of experience in product development within the medical device or other regulated industry.
Demonstrated experience in working on projects at various stages from concept through commercial launch is preferred.
Demonstrated technical contributions to a project or product in at least one technical discipline. Demonstrated expertise in multiple disciplines is a plus.
DESIRED KNOWLEDGE, SKILLS AND ABILITIES:
Requirements Development & Management
Able to translate customer needs / user needs / stakeholder needs into a set of technical requirements and ultimately a technical solution.
Able to write clear, concise, and testable functional and non-functional requirements for products and subsystems
Mechanical Design and Analysis
Able to read and understand 2D/3D CAD drawings and models
Familiar with various fabrication methods for parts and components is desirable
Able to perform rudimentary engineering analysis of components or subsystems is desirable
Electrical Design and Analysis
Able to read and understand electronic schematics
Able to perform rudimentary engineering analysis of electronic circuits
Familiar with design of analog and digital circuitry, microcontrollers, sensors, and power management
Ability to write, test, and debug firmware is helpful
System Design and Analysis
Able to perform data-centric trace-off analyses of various design options
Able to develop system or subsystem definitions using functional, logical, and physical views is desirable
Working knowledge of SysML or UML is desirable
Experimental Design and Data Analysis
Able to write and execute test protocols
Able to analyze data sets using statistical principles.
Able to create experimental designs and DOEs using statistical principles is desirable
Experience using Minitab or other statistical analysis software package is preferred
Understand and generate deliverables related to design controls in support of a regulated industry
Familiarity with 21 CFR Part 820 and ISO 13485 is highly preferred
Knowledge and experience with ISO 14971 standard is preferred
Communication and Teamwork
Excellent communication skills in written and verbal form.
Fosters effective communication across the organization and across disciplines
Primary Work LocationUSA MA - Andover
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