Job Description –
Medical Device Systems Engineer
Onsite – Cary, NC
This position is expected to convert permanent at the 6-9 month mark and the client does not offer visa sponsorship. I really just need someone from a Medical Device company like a surgical company (Plexus, stryker, boston scientific, algin, Prometheus group, Medtronic) They can be a Systems Engineer, Quality Engineer, Product Owner etc.. They need to work on lots of RISK for digital applications or SAMD or MDDS (which will likely not be in a resume, will probably just be called software or application) that run on medical devices. For example, an ECG, software for mammograms, sleep software, rpm software for vital signs, glucose monitoring, etc.. I just researched some of it.. So risk management, risk assessments, gathering requirements and writing report, writing risk files..Must-Haves:
Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable system of systems
Experience writing risk files, assessing them, socialize and review them.
Bachelors degree in an engineering discipline with 10 + years of experience
Experience with Digital Applications (SaMD. MDDS) connected to regulated electro-mechanical devices in a clinical environment preferred.
Experience with cloud service providers
Experience with 14-9-7-1 (the international standard for medical standards
Experience with development in an agile environment with experience creating and maintaining product backlogs
Excellent oral and written communication skills and ability to speak with customers
Experience in a regulated industry preferred
Excellent documentation skills.Job Description:o Drive the implementation of best practices in software systems development and product lifecycles in collaboration with development and verification teams, for Digital Applications that are part of infusion pumps ecosystemo Be a technical leader providing team members guidance and feedback on technical work.o Develop technical solutions to complex software system problems and deliver high-quality solutions on tight scheduleso Lead efforts with cross-functional team members (e.g. Commercial and Clinical) to document user needs and translate them to user needs into system requirements.
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