Staff Systems Engineer
We are seeking an experienced Staff Systems Engineer with a strong electromechanical medical design and development background to join our team at Morgan McKinley.
About the Role
As the Staff Systems Engineer, you will contribute to cross-disciplinary product development teams and may lead the definition, design, and execution of Systems Engineering activities throughout all phases of the product lifecycle.
Responsibilities
* Working with stakeholders to document System or Product-level requirements and manage changes via a cross-functional review, approval and release process.
* Updating and maintaining the system design architecture to reflect design decisions in collaboration with Marketing, Technical and cross-functional R&D leads.
* Collaborating with cross-functional R&D teams to ensure product specification documentation is updated and maintained.
* Ownership of system and application FMEAs through collaboration with cross functional teams to ensure risks are identified and controlled.
* Ensuring design traceability from customer requirements to test evidence through the creation of Requirements Trace Matrix documents. Supports cross-functional collaborators to ensure subsystem requirements and test evidence are traced. Must be proficient in the use of AzureDevOps for the purpose of design traceability and requirements management.
* Collaborating closely with Technical Leads and Quality Engineering to ensure formal qualification of designs meets product and customer requirements and risks are captured and controlled.
* Leading aspects of phase gate design reviews, e.g. review of system level design control deliverables.
About You
* Bachelor's degree in engineering or science with 8+ years related work experience required (combination of work experience and advanced degrees).
* Extensive background in electro/mechanical medical device design and development.
* A strong technical background and experience within Systems Engineering - Requirements Management, Hazards Analysis, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Reliability Engineering, and Failure Modes Effects Analysis.
* Ability to self-direct and manage own work while possessing strong interpersonal skills with the ability to collaborate in multi-disciplinary team settings, influence decision making, and build group consensus.
* Perform in a fast-paced, multiple global team agile environment.
* Collaborative leader focused on success of overall project; capable of inspiring others and leading without authority.
* /Self-starter/ attitude and the ability to make decisions with minimal oversight.
* Excellent written and oral communication skills.