Principal Systems Engineer, R&D - Advanced Patient Monitoring

About This Role

Join a dynamic team as a Principal Systems Engineer to lead the design, development, and implementation of complex medical systems and devices, focusing on medical technology and advanced algorithms to improve patient outcomes. This role involves critical work in advanced patient monitoring within BD's medical segment.

Responsibilities

• Write and implement Design Verification Protocols while effectively organizing, capturing, and analyzing test results
• Plan, collect, and translate detailed information about user interactions with Critical Care medical devices and connectivity solutions through various methods (interviews, field observation, task analysis, simulation labs)
• Support system requirements development and management related to device connectivity, usability, user experience, and testing
• Provide technical support to Regional Marketing and Sales teams for pre-sale efforts
• Support communication with hospital IT departments for initial deployment questions, setup, and testing strategy
• Work with sales, marketing, and quality/complaint handling teams for post-market surveillance
• Drive technical root cause investigations, engaging appropriate R&D, quality, and vendor resources
• Identify/create new product features and collaborate with Software development team through clear communication, wireframes, and storyboards
• Navigate tasks through multi-functional teams during product development

Requirements

• 5+ years of experience in a systems engineering role
• Experience leading complex medical device development from concept to market
• Strong knowledge of regulatory requirements and quality standards in the medical device industry (FDA, ISO 13485, ISO 60601)
• Experience with requirement management tools (PTC, JAMA, or DOORS)
• Availability for up to 25% domestic and international travel

Qualifications

• Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or Mechanical Engineering
• 5+ years of experience in a systems engineering role

Nice to Have

• Advanced degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or Mechanical Engineering
• Experience in systems engineering in the MedTech industry
• Prior clinical experience in Critical Care monitoring (hemodynamic monitoring, vital sign's monitoring), Interventional, Vascular, or Cardiac Surgery
• Good understanding of design controls (IEC 62366, ISO 14971, 21 CFR 820)
• Experience with Device Connectivity and Cloud-based application solutions

Skills

* Required skills

Benefits