Engineer III, Systems Engineering

Becton Dickinson Medical Devices • San Diego, CA

2d • Onsite

About The Position

Sr. Engineer, Systems Engineering is responsible for using their technical expertise, collaboration and communication skills, and medical device development knowledge to drive R&D new product development and in market product milestones to completion. In this role, you are expected to translate voice of customer and stakeholder needs into system and product requirements, identify potential hazards and assesses requirements to ensure product compliance to safety and regulatory standards, drive product design architecture definition, proactively identify technical risks and mitigation pathways, lead and perform informal and formal system level requirement verification and user validation, and support engineering teams in developing design specifications for medical device systems with mechanical parts, electronics, software, and/or algorithms. The expectation for Engineer III, Systems Engineering is that they support the R&D function on project teams, demonstrate technical excellence, and strive for continuous improvement within the Systems Engineering function. As such, they are expected to drive their assigned R&D milestones to completion to ensure planned project milestones are met. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Sr. Engineer, Systems Engineering is responsible for using their technical expertise, collaboration and communication skills, and medical device development knowledge to drive R&D new product development and in market product milestones to completion. In this role, you are expected to translate voice of customer and stakeholder needs into system and product requirements, identify potential hazards and assesses requirements to ensure product compliance to safety and regulatory standards, drive product design architecture definition, proactively identify technical risks and mitigation pathways, lead and perform informal and formal system level requirement verification and user validation, and support engineering teams in developing design specifications for medical device systems with mechanical parts, electronics, software, and/or algorithms. The expectation for Engineer III, Systems Engineering is that they support the R&D function on project teams, demonstrate technical excellence, and strive for continuous improvement within the Systems Engineering function. As such, they are expected to drive their assigned R&D milestones to completion to ensure planned project milestones are met.

Requirements

• Must have a Bachelor’s degree in Engineering.
• 3 years related work experience (or combination of work experience and advanced degrees).

Nice To Haves

• A post graduate degree is desired.
• A strong technical background and experience within systems engineering in the medical device industry (Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis), and/or other engineering disciplines within the medical device industry, such as mechanical engineering, biomedical engineering, electrical engineering, or software engineering.
• Ability to work independently and as a member of a cross-functional medical device team.
• Ability to collaborate productively within multi-discipline engineering teams that may consist of mechanical engineers, electrical engineers, software engineers, biomedical engineers, and algorithm engineers to meet planned milestones.
• Excellent cross-functional communication skills, strong technical writing skills, attention to detail, and demonstrated ability to bring clarity to ambiguous areas to drive decisions.
• Demonstrated history of achievement, learning agility, and action orientation.
• Experience with medical device new product development.
• Hands-on experience with Design for Six Sigma and/or experience with experimental design and data analysis.
• Experience creating and maintaining Requirements Traceability Matrices and Verification Plans at system and subsystem levels.
• Hands-on proficiency with data acquisition tools, measurement systems, and test automation (e.g., Python/NI/LabVIEW) for verification.
• Working knowledge of statistical methods for verification (e.g., tolerance analysis, confidence/reliability planning, equivalence testing).
• Demonstrated ability to write clear verification protocols and reports suitable for design reviews and regulatory submissions.

Responsibilities

• Demonstrate knowledge of system-level medical device technology with mechanical parts, electronics, software, and algorithms
• Demonstrate knowledge of the medical device product development lifecycle and standards
• Ability to translate voice of customer and stakeholder needs into system and product requirements
• Responsible for coordination of aspects of system-level new product development and its integration
• Responsible for aspects of informal and formal system level requirement verification and user validation
• Lead aspects of system and product-level feasibility and risks assessments
• Facilitate cross-functional team knowledge sharing and experiences to promote the understanding and resolution of in-market and new product development issues
• Bring system level technical issues to resolution
• Identify potential hazards and associated risk control measures
• Demonstrate knowledge of clinical environments and clinical aspects of medical device usage
• Demonstrate or develop knowledge in signal processing and/or algorithm development
• Identify opportunities and drive continuous improvement efforts
• Apply experience in and best practices to experimental design and data analysis
• Develop, own, and maintain the System Test Protocols (TP) aligned to the system and product requirements, including scope, acceptance criteria, environments, and traceability.
• Create and manage requirements traceability (e.g., RTM) ensuring full bidirectional linkage between user needs, system/product requirements, risk controls, and verification test cases.
• Author clear, unambiguous verification protocols and test methods (bench, electrical, software, and integrated system) and associated data collection forms.
• Execute verification testing (or coordinate execution with labs/partners), ensuring proper test setup, calibrated equipment, sample accountability, and adherence to good documentation practices.
• Analyze results, perform statistical treatment as appropriate (e.g., confidence/reliability calculations, sample size rationale), and document objective evidence against acceptance criteria.
• Establish verification environments, fixtures, and automation scripts where practical to improve repeatability, throughput, and coverage.
• Collaborate closely with Design, Firmware/Software, Electrical, Mechanical, Quality, and Clinical to clarify requirements, define testability, and decompose system requirements into verifiable specifications.
• Ensure verification activities address risk controls derived from hazard analyses (e.g., FMEA, Fault Tree) and confirm risk mitigations are verified.
• Prepare and present verification readiness/closure reviews; compile complete System Test Reports (TR) suitable for design reviews and regulatory submissions.
• Maintain verification records to company quality system procedures, including configuration control of test methods, protocols, deviations, and raw data.

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
• Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees