Systems Engineer

iotaMotion·
Pittsburgh, PA
3mo ago
Full-timeMidR&DMedical DeviceUnknownBachelors
$85K - $250K/yr

Description

iotaMotion is hiring a Medical Device Systems Engineer (SE) to join an in-office R&D team at our Pittsburgh, PA location. iotaMotion develops and commercializes robotic-assisted surgical technologies. The first commercially available product is iotaSOFT® Insertion System, which controls the insertion of a cochlear implant to improve outcomes for surgeons and subsequently patients. As a member of our team, you will have the opportunity to engage with surgeons to optimize their treatment of those with hearing loss. Responsibilities include managing and owning all aspects of system requirements and validation planning for new product development, driving requirements discussions, managing Usability Engineering deliverables, understanding design impacts, collaborating with test engineers, working with project managers, driving risk management initiatives, interfacing with Regulatory Affairs, supporting technical documentation generation, consulting on training material development, and participating in post-market surveillance and customer support activities throughout the product life-cycle.

Requirements

Must have a Bachelor’s degree in Engineering or a related field plus a minimum of 5 years of post-baccalaureate experience in the job offered or related role in the Medical Device industry. Of the required experience, candidates must have 4 years of experience working with healthcare professionals to turn user requirements into technical requirements, writing and managing system requirements for a Medical Device, authoring verification and validation test plans and protocols and executing tests, authoring and/or participating in design reviews, design FMEAs, and documentation for regulatory submissions, performing user needs -> requirements -> design outputs -> validation/verification trace activities, designing/managing usability studies.
iotaMotion

iotaMotion

MEDICAL DEVICES

Cochlear Implant Insertion Robots

LocationIA - Iowa City
Open Jobs2
Medical DeviceUnknown
View Company Profile

Pipeline

Cochlear Implantation with Robotic-Assisted Insertion SystemN/A
iotaSOFT Insertion SystemN/A
iotaSOFT Insertion SystemN/A
iotaSOFT Insertion System with AIMN/A