Senior Systems Engineer – Medical Devices & MBSE

bdx; San Diego (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD in San Diego is seeking a Staff Systems Engineer to provide technical leadership across complex medical device product development programs. You will translate customer needs into system requirements, guide architecture, manage risk, and drive verification and validation.

You will mentor other engineers, advance MBSE and DFSS practices, collaborate with regulatory, software, hardware, and manufacturing teams, and help shape systems engineering strategy for multiple portfolios.

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 6-8+ years of relevant engineering experience.
• Demonstrated success leading systems engineering for complex products.
• Deep understanding of product development lifecycle from concept to sustaining support.
• Expertise in requirements development, management, and traceability.
• Experience defining system architectures and technical strategies.
• Experience leading system verification, validation, integration, and risk management.
• Strong communication and cross-disciplinary influence.

Responsibilities

• Provide systems engineering leadership across multiple product development programs.
• Lead system-level activities through lifecycle from concept to sustaining support.
• Translate customer needs into system requirements and product solutions.
• Develop and manage system requirements, traceability, and design inputs.
• Define system architecture strategies balancing needs, feasibility, and regulatory requirements.
• Lead risk management activities including hazard analysis and FMEA facilitation.
• Provide technical leadership for integration planning and issue resolution.
• Establish verification/validation strategies and ensure successful execution.
• Drive reliability planning and data-driven quality improvements.
• Collaborate across cross-functional teams to resolve complex challenges.
• Mentor and develop Systems Engineers and other contributors.

Skills

Bachelor's degree

6-8+ years experience

Systems engineering leadership

Regulatory knowledge

MBSE experience

DFSS knowledge

INCOSE certification

Medical device development

Agile/hybrid development

Education

Bachelor's degree in Engineering or Science

Postgraduate degree preferred

Tools

MBSE tools

INCOSE methodologies

Job description

BD in San Diego is seeking a Staff Systems Engineer to provide technical leadership across complex medical device product development programs. You will translate customer needs into system requirements, guide architecture, manage risk, and drive verification and validation.

You will mentor other engineers, advance MBSE and DFSS practices, collaborate with regulatory, software, hardware, and manufacturing teams, and help shape systems engineering strategy for multiple portfolios.