What are the responsibilities and job description for the System Engineer position at ShineBask Technologies LLC?
Medical Device Systems Engineer/Product Owner
Pittsburgh, Pennsylvania
About the Role
Medical Device Systems Engineer/Product Owner, which may widen and also focus the responses.
Responsibilities
- 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.
Qualifications
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.
Required Skills
- Experience with Cognition Cockpit, CompassMed, 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/testings, automated testing.
Preferred Skills
- 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.
Pay range and compensation package
[Pay range or salary or compensation]
Equal Opportunity Statement
[Include a statement on commitment to diversity and inclusivity.]