Job DescriptionAbout the RoleWe're looking for a Sr. Staff Systems Engineer with a strong systems mindset to lead the development and evolution of complex medical technologies. In this role, you will shape system architecture, define system-level requirements, drive integration and verification, and ensure full design control compliance throughout the product lifecycle; from concept through commercialization and post-market support.
You will collaborate with and lead cross-functional teams while mentoring engineers as you guide the technical execution of highly complex electro-mechanical medical devices. Your work ensures that our solutions meet user needs, regulatory requirements, and performance expectations. Whether you're passionate about systems thinking, product architecture, or hands-on experimentation, this role offers the opportunity to make a meaningful impact on innovative healthcare solutions.
Key Responsibilities:Systems Architecture & Requirements
- Lead systems level design and development activities for new and existing products.
- Define, maintain, and evolve system and product architectures, ensuring alignment with user needs, regulatory requirements, and business goals.
- Translate user and stakeholder needs into clear, actionable system requirements and interface definitions.
- Ensure complete traceability from requirements through design, implementation, verification, and validation.
Design Control Leadership
- Lead and review product development plans, design reviews, technical documents, and formal reports.
- Review and approve verification and validation protocols and reports per BD design control procedures.
- Develop and implement design control-related procedures/policies to ensure compliance with FDA/QSR, ISO 13485, and internal standards.
System Integration, Testing & Test Method Development
- Lead system integration activities, including defect tracking, configuration management, and risk assessment.
- Plan, execute, and analyze system-level testing, then effectively communicate insights.
- Critique and guide engineering test method development and simulated-use methods; oversee validation of these methods.
- Support test equipment development and IQ/OQ/PQ validation where applicable.
Cross-Functional Leadership & Technical Guidance
- Lead cross-functional technical reviews and risk management activities (dFMEA, hazard analysis).
- Work with marketing, sales, and clinicians to define high-level system requirements and workflows.
- Provide system-level guidance on DFM/DFSS, manufacturability, and subsystem integration.
- Ensure clear documentation of subsystem level design requirements
- Ensure accurate communication of relevant requirements for all cross functional stakeholders
Problem Solving & Innovation
- Apply creative problem-solving and critical thinking to resolve complex technical challenges.
- Lead idea generation and IP development activities; support patent submissions for system innovations.
Project Planning & Fiscal Accountability
- Develop project plans to assess complex technologies and drive execution.
- Create, lead, and control project technical budget and perform cost analyses.
- Identify and implement system-level cost improvements.
Manufacturing, Quality & Regulatory Support
- Support Manufacturing, Quality, Regulatory, and Sustaining Engineering to ensure compliance.
- Lead or support root cause investigations, non-conformances, and complaint analyses.
People Leadership
- Mentor and coach engineers and technicians.
- May supervise engineers/technicians and participate in performance feedback and hiring processes.
Required Education:- Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, Software) or Scientific field & 8 + years of experience. - OR -
- Master's Degree or equivalent in Engineering or Scientific field & 7+ years of experience with test method development and writing test plans is required - OR -
- Ph.D. or equivalent in Engineering or Scientific field & 4+ years of experience with test method development and writing test plans is required
Required Experience & Qualifications:- Validated experience in R&D for complex electro-mechanical systems, medical devices, diagnostics, lab automation, or similar.
- Previous experience working with requirement management tools such as Modern Requirements, PTC, Polarion, JAMA or DOORS.
- Experience writing system level requirements and working with different functional groups to decompose into hardware, software, usability and mechanical requirements
- Experience with writing and execution system verification and validation protocols.
- Strong understanding of IEC 6060-1 and relevant medical device standards
- Solid base in systems engineering principles, including requirements management, architecture development, integration, and verification.
Preferred Qualifications:- Comfortable navigating ambiguity and driving clarity in fast-paced, agile environments.
- Effective communicator and collaborator with the ability to influence across functions and lead without formal authority.
- Demonstrated ability to lead technical complexity and deliver results in cross-functional project teams.
- Self-motivated, curious, and eager to learn new technologies and approaches.
Travel Requirements:- This position requires 15-25% travel to support system-level development activities. Travel may include visits to BD design centers, manufacturing sites, supplier facilities, and preclinical or clinical environments. A large portion, especially during onboarding, will involve regular collaboration with our engineering teams in Ireland, including onsite work to support system integration builds, design reviews, verification and validation activities, and cross-functional alignment.
Physical Demands:- Regular standing, walking, sitting, verbal communication; occasional reaching, kneeling, crouching.
Work Environment:- Will work in office, lab, preclinical, or clinical case environments.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Primary Work LocationUSA AZ - Tempe Headquarters
Additional LocationsWork Shift 
