- 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.
- Incorporates business, market, industry, and competitive knowledge into technical solutions.
- Determines required tasks and completes on time with minimal supervision.
- Identifies and communicates potential risks with appropriate mitigations.
- Synthesizes complex information gathered from a variety of sources and disseminates to others.
- Additional duties as assigned.
- Bachelor's degree with 3+ years of medical device development experience is highly desirable
- Involvement with medical device regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and ISO 13485 including experience with system risk/hazard analysis
- Experience with FDA 510(k) product/testing requirements
- Excellent IT/computer skills and a willingness to learn new tools as they become relevant
- Flexibility and ability to self-start on new challenges, problem-solving with minimal supervision
- Ability to work efficiently on multiple tasks with deadlines
- Ability to work in a diverse team with members of varying education and experience levels
- Creative/innovative, able to rapidly problem-solve and work well given typical project schedules
- Superb organizational and multitasking skills as well as strong written and verbal communication skills
- Familiarity with ISO and IEC standards pertaining to medical devices
- Proficiency with functional analysis and cascading down from user level to subsystem/ component level of customer requirements
- Experience working in Quality or Regulatory capacities in the medical device industry
- 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
- Ability to work effectively in a multidisciplinary team while maintaining independence from technical development
- Strong analytical skills and willingness to develop understanding of relevant concepts in medicine and mechanical, electrical, and materials engineering
- Demonstrable experience in performing risk assessment, software validation and testing
-
Skyline Ventures Cleveland, United StatesAs an experienced System Engineer (m/f/d), you will implement complex infrastructure projects for our clients in the Microsoft world, whether in the cloud or on-premises, as well as in virtual environments with VMware. The location is Leverkusen with the option for home office (t ...
-
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 ...
-
System Engineer
3 weeks ago
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, ...
-
IT Systems Engineer
3 weeks ago
Omega Ventures Cleveland Heights, United StatesAs part of the FRANK family, you will work with us to create a sustainable and economically sound future. · For over 50 years, FRANK GmbH has been a leading provider in the plastic pipe market as a family-owned company. We develop, produce, and distribute plastic pipe systems mad ...
-
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 ...
-
Systems Engineer
3 weeks ago
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 ...
-
Systems Engineer
1 week ago
JOANN Stores Cleveland, United StatesThe Technical Engineer will join a group of IT professionals focusing on technology such as servers, operating systems, databases, web application servers and local area, wide area and wireless networks. JOANN utilizes industry-leading technology fro Systems Engineer, Systems, Te ...
-
Systems Engineer
3 weeks ago
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: ...
-
Systems Engineer
3 weeks ago
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, ...
-
System Engineer
3 weeks ago
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 ...
-
Systems Engineer
3 weeks ago
Research Group Cleveland, United StatesJob Description · Job DescriptionJob Description · Responsibilities · Responsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform. · Develops/maintains system architecture and interface requirements for the products, bas ...
-
System Engineer
3 weeks ago
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 ...
-
System Engineer
5 days ago
Palo Alto Networks Cleveland, United StatesOur 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 company built on the fou ...
-
IT System Engineer
3 weeks ago
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 ...
-
System Engineer
3 weeks ago
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 ...
-
Systems Engineer
3 days ago
Pansophic Learning Cleveland, United StatesJob Description · Job DescriptionAbout the Opportunity · "We believe that every child should be able to be anything they want in life, regardless of their birthplace and circumstances." – Ron Packard, CEO & Founder · Pansophic Learning is an education company that strives to prov ...
-
IT System Engineer
3 weeks ago
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 ...
-
IT System Engineer
3 weeks ago
Skyline Solutions Summit, United StatesIT System Engineer (m/f/d) Microsoft Technologies Server & Cloud at Summit · We are looking for you to join our headquarters in Hannover as an IT System Engineer (m/f/d) for Microsoft Technologies Server & Cloud at Summit as soon as possible. As a creative and technically-minded ...
-
System Engineer
2 weeks ago
Palo Alto Networks Cleveland, United StatesJob Description · Job DescriptionCompany 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 ...
-
Systems Engineer
2 weeks ago
Motorola Solutions Cleveland, United States Regular, Full timeCompany Overview · At Motorola Solutions, we're guided by a shared purpose - helping people be their best in the moments that matter - and we live up to our purpose every day by solving for safer. Because people can only be their best when they not only feel safe, but are safe. W ...
Systems Engineer - Cleveland, United States - Centerline Biomedical
Description
Position 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.
Together with the development team, the Systems Engineer is responsible for investigation, evaluation, and selection of the best system structure and documentation.
Responsibilities/Duties:
Education and Experience:
Abilities:
Work Conditions:
Work is performed primarily in a standard office environment.
Essential functions require sufficient physical ability and mobility to work in an office setting; to stand or sit for prolonged periods of time; to occasionally bend, kneel and reach; to lift, carry, push/pull light to moderate amounts of weight; to operate office equipment that may require fine motor coordination (i.e., use of a keyboard).
Reasonable accommodations may be made when an employee has a qualified disability but can still perform the essential functions of the job (without creating an undue hardship).
Systems Engineer professionals in Cleveland
-
Osvaldo Arturo Tapia Dueñas
Computer Science Research
-
MAUREEN CAMPBELL
Enterprise Digital Transformation Architect
-
Martin Thomas
Certified PMP/Program Development & Implementation
-
Xavier Williams
Biomedical Engineer
-
Khaled Younis
Machine Learning Expert