Medical Device Systems Engineer

On-Site: Medical Device Systems Engineer with Robotics and/or Medical Devices Experience _ Pittsburgh, Pennsylvania

Location: Pittsburgh, Pennsylvania

Duration: 7-month contract

All visa

This role requires working onsite 5 days a week in Pittsburgh, Pennsylvania.

This role has a 2–3 step virtual interview process and, since it’s a contract position, they can work with any sponsorship.

The one hard requirement is candidates must have a background in robotics and/or medical devices.

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 iota SOFT® 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.

Ideal Applicants will have:

• -Experience with Cognition Cockpit, Compass Med, DOORS, or other requirements management tooling
• -Deep Software Requirement development experience, especially translating Customers’ Needs to efficient Software workflow and formal Software Requirements.
• -Deep experience building Subsystem, Integration, and System Software verification plans
• -Experience with 60601 testing, especially for electromechanical devices
• -Practical experience with CAD (ESP SolidWorks), Embedded System design/testing, Microcontroller development/testing, automated testing

Position responsibilities include but are not limited to:

• Manage and own all aspects of system requirements and validation planning for new product development.
• Drive requirements discussions to turn User Requirements into testable Product Requirements.
• Manage Usability Engineering deliverable, including planning, execution, and reporting of usability evaluations.
• Understand impact of detailed design on the overall system to create detailed test strategies.
• Collaborate with test engineers to author verification plans, protocols, test cases, summary reports, trace matrix, and other related technical documentation.
• Work with project managers and hardware/software engineers for execution for key programs and releases.
• Work with quality engineers to drive risk management initiatives in support of Design Controls.
• Interface with Regulatory Affairs and support regulatory assessments and documentation, including pre-sub.
• Support review and generation of technical documentation including IFU, technique guide, user manual, etc.
• Consult on training material development, field team training, and product launches
• Participate 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, must have 4 years of experience in the following:
• 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 (such as for FDA, EU MDR)
• Performing user needs -> requirements -> design outputs -> validation/verification trace activities
• Designing/managing usability studies