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BD (Tissuemed Ltd) · 1 day ago

Sr. Principal Systems Engineer

Irvine, CA

Full-time

Onsite

Senior Level

$125K/yr - $206K/yr

4+ years exp

BD is one of the largest global medical technology companies in the world, dedicated to advancing health. As a Senior Principal Systems Engineer, you will be responsible for developing and maintaining system requirements and architecture for new products, collaborating with various disciplines to support new product development in the Advanced Patient Monitoring business.

Health CareHospitalMedicalMedical Device

Responsibilities

Works directly with marketing, field sales, and clinicians to define high level system requirements, product concepts, user interfaces, patient-contact parts and disposables, and interfaces to external systems and medical devices.Initiate and lead in the improvement, design and optimization of highly complex experiments and tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products

Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications

Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work

May lead cross functional teams through complex design control activities including requirement specs, and risk documents with substantial knowledge on design control requirements

Develop project plans to assess complex technology and drive project results

Provide direction and guidance on strategies related to technical solution areas

Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems

Train, coach, and guide lower level employees on more complex procedures

Qualification

Medical device experienceTest method developmentSystem verification protocolsStatistical analysisElectromechanical instrumentationRequirement management toolsIEC 60601 standardsProject managementCross-functional collaborationAdaptability

Required

Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, Software) or Scientific field & 8 + years of experience

Master's Degree or equivalent in Engineering or Scientific field & 7+ years of experience with test method development and writing test plans is required

Ph.D. or equivalent in Engineering or Scientific field & 4+ years of experience with test method development and writing test plans is required

Has previously worked in the medical device industry

Statistical experience is required

Has previous experience working with electromechanical instrumentation

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