- Responsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform.
- Develops/maintains system architecture and interface requirements for the products, based on technology and platform strategies.
- Defines subassembly interfaces and subassembly requirements to both internal and outsourced design teams.
- Implements and tests the product platform to ensure high quality, robust behavior and safety in accordance with medical device regulatory standards and customer requirements.
- Responsible for daily system engineering activities including leading issue resolution and communication across teams in order to deliver results on-time and on-budget.
- Develops/maintains the risk management file in accordance with ISO 14971 and ensures product safety in accordance with IEC and its appropriate subparts.
- Works with other team members and functions to execute design reviews of complex Medical Devices.
- Drives structural design documentation and plans by applying engineering best practices.
- Conducts impact analysis for design changes and implements necessary actions including estimates of impact to time, budget, and scope.
- Effectively coordinates test activities throughout the project to drive efficiency in V&V in collaboration with the regulatory resource to ensure a complete and effective 510(k) submission.
- Understands and follows quality and product development processes.
- A Bachelor's degree is required.
- 3+ years of Systems Engineering experience.
- Industry experience must be from a regulated environment such as Medical Device, Aerospace, Military, Space or Automotive.
- Product development experience is highly desirable.
- Involvement with regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and/or ISO 13485.
- Experience with system risk/hazard analysis.
- Experience with FDA 510(k) product/testing requirements is a plus.
- Experience working in Quality or Regulatory capacities in the medical device industry is ideal.
- Skilled in developing test plans and validation protocols in a regulated environment.
- Capability of using automated software testing tools.
- Familiarity with numerical analysis and methods.
- Demonstrable experience in performing risk assessment, software validation and testing.
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Omega Ventures Cleveland, United StatesCleveland is seeking a Chief Avionic System Engineer (m/w/d) to join our team in the Bodensee or Frankfurt area. As the Chief Avionic System Engineer, you will be responsible for the development of system architectures and design solutions. This includes identifying and coordinat ...
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BlueWave Solutions Seven Hills, United StatesAt the world market leader in energy technology, you will contribute to ensuring a stable energy supply in the future. With our intelligent digital and analog solutions, you will shape the implementation of the energy transition. Join a global team of 3,800 dedicated colleagues, ...
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Eclipse Innovations Cleveland, United StatesWe are looking for three employees to join our construction project management team in the Technical Planning and Execution department. This is a full-time (38 hours) or part-time position with an indefinite contract, with a salary based on pay group 12 of the TV-N Berlin (€4, €4 ...
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Centerline Biomedical Cleveland, United StatesPosition Summary: · The Systems Engineer is an Exempt/Full-Time position that works alongside the development team to ensure product specifications are achieved and in compliance with medical regulatory practices and company procedures. The role assists in system risk analysis, ...
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Centerline Biomedical Cleveland, United StatesPosition Summary: · The Systems Engineer is an Exempt/Full-Time position that works alongside the development team to ensure product specifications are achieved and in compliance with medical regulatory practices and company procedures. The role assists in system risk analysis, ...
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Fortinet Cleveland, United StatesWe are looking for a Systems Engineer to work closely with a Named Account Manager in a defined territory. The Systems Engineer's main mission will be to support the sales organization in all technical matters regarding pre-sales, sales calls, and post-sales. · Responsibilities: ...
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Research Group Inc Cleveland, United StatesCompany Description · Job Description · ResponsibilitiesResponsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform. · Develops/maintains system architecture and interface requirements for the products, based on technol ...
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Research Group Inc Cleveland, United StatesJob Description · Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below. · Responsibilities · Responsible for overall system engineering / testing for a complex electromagnetic surgical navigation product plat ...
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Insight Global Cleveland, United StatesInsight Global is seeking a System Engineer for one of our clients in the education management industry. Our client is a growing leader in the education space, operating schools and educational programs around the world that span the life cycle of a student from early learning to ...
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Palo Alto Networks Cleveland, United StatesCompany Description · Our Mission · At Palo Alto Networks everything starts and ends with our mission: · Being the cybersecurity partner of choice, protecting our digital way of life. · Our vision is a world where each day is safer and more secure than the one before. We are a ...
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Aurora Technologies Royalton, United Statesdacapo IT solutions is a continuously growing IT system house in Kempten. We support the IT systems of companies in the region under the motto: "Your IT - from person to person". · Your career at dacapo IT solutions means for us to support you in achieving your personal goals in ...
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Palo Alto Networks Cleveland, United StatesCompany Description · Our Mission · At Palo Alto Networks everything starts and ends with our mission: · Being the cybersecurity partner of choice, protecting our digital way of life. · Our vision is a world where each day is safer and more secure than the one before. We are a co ...
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BlueWave Ventures Willowick, United StatesAbout NetPlans GmbH: · We are one of the leading providers nationwide for the planning, implementation, and support of IT infrastructures, managed services, and cloud solutions. · What do we offer? · Attractive, performance-based salary model · Permanent employment contract · Com ...
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Infinity Systems East Glenville, United StatesWe are looking for three employees to join our construction project management team in the Technical Planning and Execution department at East Glenville. This is a full-time (38 hours) or part-time position with an indefinite contract, with a salary according to pay group 12 TV-N ...
Systems Engineer - Cleveland, United States - Research Group
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