Job Title: Systems Engineer
We are seeking a highly skilled Systems Engineer to contribute to our cross-disciplinary product development teams.
Main Responsibilities:
* Ownership of Systems Engineering inputs and deliverables for teams supporting either NPD or released product.
* Working with stakeholders to document System or Product-level requirements and manage changes via a cross-functional review, approval and release process.
* Responsibility for 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 FMEA's 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.
* Supporting 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.
Requirements:
1. Bachelor's degree in engineering or science with at least 8 years' related work experience.
2. Extensive background in electro-mechanical medical device design and development.
3. A strong technical background and experience within Systems Engineering – Requirements Management, Hazards Analysis, System Architectural Development, Functional Modelling, Systems Integration, Statistical Test Design, Verification and Validation, Reliability Engineering, and Failure Modes Effects Analysis.
4. 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.
5. Perform in a fast-paced, multiple global team agile environment.
6. Collaborative leader focused on success of overall project; capable of inspiring others and leading without authority.
7.