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Senior Principal Systems Engineer-Surgical
| Company | Medtronic |
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| Location | Boston, MA, USA |
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| Salary | $156000 – $234000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior, Expert or higher |
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Requirements
- Mastery of Systems Engineering principles and practices
- Track record of working independently and setting priorities to implement strategic goals
- Experience developing risk management files and applying risk management best practices and principals to medical device development
- Demonstrated expertise in new product development of complex, software controlled electromechanical systems; ideally systems of systems
- Robust ability to effectively communicate complicated information with internal, external, and non-technical audiences
- Excellent understanding of design controls and good documentation practices
- Advanced knowledge of standards including IEC 60601, ISO 14971, ISO 13485 and 62366
- Bachelor’s degree in Biomedical, Electrical, Mechanical, or Systems Engineering required
- Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience
- Fluency in English and authorization to work in the US is required
Responsibilities
- Report to a Systems Engineer Manager within the Systems Center of Excellence of the Surgical Operating Unit
- Actively participate in regular R&D project team meetings for the development of new complex surgical systems
- Lead a group of systems engineers in the development and timely delivery of systems design control deliverables
- Develop and review solution architectures and safety strategies for systems of systems
- Apply Systems Engineering principles and best practices to new product development
- Actively contribute to risk management including hazard analysis, usability risk analysis, and risk mitigation
- Communicate progress and roadblocks to project management organization and technical leadership
- Direct the day-to-day activities of, and mentorship to junior systems engineers
- Provide post commercialization product support including root cause investigation and resolution activities
Preferred Qualifications
- Advanced degree in Biomedical, Electrical, Mechanical, or Systems Engineering
- Experience with ANSI/AAMI/UL 2800-1:2022
- Experience with medical robotics and combination capital-disposable equipment
- History of negotiating with internal and external groups to reach common understanding and achieve shared goals
- Demonstrated ability to strongly influence the design of new products and direct team activities without direct authority
- Mastery-level knowledge of requirements management, risk management, and system architecture development
- Deep knowledge in hardware, software, and electrical engineering practices and product development
- Practical experience utilizing Model Based Systems Engineering in product development
- Proven track record of developing complex products in a highly regulated environment
- Experience working with multiple teams on concurrent, interdependent projects
- Solid understanding of structured product development (requirements-driven engineering, documentation, rigorous verification, etc.)
