
Sr. Systems Engineer, R&D - BD Advanced Patient Monitoring
- Irvine, CA
- $102,000-168,200 per year
- Permanent
- Full-time
- Write and execute 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
- Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or Mechanical Engineering
- 3+ or more years of demonstrated ability in systems engineering (MedTech industry preferred)
- Consistent track record of 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)
- Excellent problem-solving skills and ability to work effectively in a fast-paced, collaborative environment
- Strong communication and interpersonal skills, with ability to convey technical information to non-technical stakeholders
- Experience with requirement management tools (PTC, JAMA, or DOORS)
- Self-motivated with ability to achieve results with minimal direction
- Availability for up to 25% domestic and international travel
- Prior clinical experience in Critical Care monitoring (hemodynamic monitoring, vital signs 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