BD (Tissuemed Ltd) · 1 month ago
Principal Systems Engineer, R&D - BD Advanced Patient Monitoring
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $206K/yr
5+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health through innovative solutions. The Principal Systems Engineer will be responsible for the design, development, and implementation of complex medical systems and devices, contributing to improved patient outcomes and quality of life in healthcare.
Health CareHospitalMedicalMedical Device
Responsibilities
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
Qualification
Required
Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or Mechanical Engineering
5+ 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
Preferred
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
Benefits
Competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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