Systems Engineer II
4 weeks ago
We are seeking a highly skilled Systems Engineer II to join our team at Medtronic. As a key member of our Systems Engineering Team, you will be responsible for collaborating with cross-functional teams to design, develop, and test complex electromechanical medical devices.
Key Responsibilities:
- Assist in requirements development and traceability
- Contribute to functional analysis and decomposition
- Document system and subsystem architecture
- Understand, evaluate, and communicate system performance, desired behavior, and usability in the context of clinical use
- Engage with design quality assurance in risk management activities
- Employ Model Based Systems Engineering to document and communicate system design
- Investigate system integration issues to identify root cause and propose resolution
- Hands-on work with products in simulated use environments
- Work closely with verification and validation engineers to review and refine test methods, protocols, and reports
- Support Systems Engineering activities throughout the product lifecycle including design change impact analysis, labelling and packaging requirements, field issue investigation
Requirements:
- Working knowledge of Systems Engineering principals and best practices
- Strong communication skills
- Experience in new product development
- Experience developing complex electromechanical medical devices
- Experience with design controls and good documentation practices
- Awareness of standards including IEC 60601, ISO 14971, ISO 13485 and 62366
- Bachelor's degree in Biomedical, Electrical, Mechanical, or Systems Engineering required
- Advanced degree in Biomedical, Electrical, Mechanical, or Systems Engineering
- Minimum of 2 years' experience as a contributing member to engineering projects
- Strong organization acumen with the ability to communicate effectively to non-technical audiences
- Demonstrated ability to collaborate and contribute to a cross functional product development team
- Knowledge of requirements management, risk management, and system architecture documentation
- Familiarity with tools such as Enterprise Architect, Jira, Jama, and Oracle Agile
- Experience working on products of high complexity in a regulated environment
- Understanding of structured product development
What We Offer:
- Competitive salary and flexible benefits package
- Opportunity to work on complex electromechanical medical devices
- Collaborative and dynamic work environment
- Professional development opportunities
How to Apply:
If you are a motivated and detail-oriented Systems Engineer II looking to join a dynamic team, please submit your application.
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